U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The application may underestimate the eroa (effective regurgitant orifice area) in comparison to the same patient results obtained with the 4z1c volume transthoracic echocardiography transducer.
Acción
Siemens sent a Customer Notification letter to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact your Customer Care Center.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.
Acción
The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following:
Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately.
Step 2a: If you HAVE inventory of any of the devices with the lot codes listed on the notice, complete the business reply form and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac
Step 2b: If you DO NOT HAVE any affected devices to return, please complete the business reply form, indicating you have no devices and return by one of the means listed below:
1. Email to: padpro2602@conmed.com
2. Fax to: Field Action Support Team at 315-624-3225.
3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team
If you have any questions or requests, please don't hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email padpro2602@conmed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.
Acción
The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following:
Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately.
Step 2a: If you HAVE inventory of any of the devices with the lot codes listed on the notice, complete the business reply form and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac
Step 2b: If you DO NOT HAVE any affected devices to return, please complete the business reply form, indicating you have no devices and return by one of the means listed below:
1. Email to: padpro2602@conmed.com
2. Fax to: Field Action Support Team at 315-624-3225.
3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team
If you have any questions or requests, please don't hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email padpro2602@conmed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and unique device identification (udi) information.
Acción
On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following:
Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions:
1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above.
2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned.
3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned.
4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990.
5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International.
6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.
Acción
The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following:
Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately.
Step 2a: If you HAVE inventory of any of the devices with the lot codes listed on the notice, complete the business reply form and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac
Step 2b: If you DO NOT HAVE any affected devices to return, please complete the business reply form, indicating you have no devices and return by one of the means listed below:
1. Email to: padpro2602@conmed.com
2. Fax to: Field Action Support Team at 315-624-3225.
3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team
If you have any questions or requests, please don't hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email padpro2602@conmed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and unique device identification (udi) information.
Acción
On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following:
Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions:
1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above.
2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned.
3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned.
4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990.
5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International.
6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.
Acción
The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following:
Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately.
Step 2a: If you HAVE inventory of any of the devices with the lot codes listed on the notice, complete the business reply form and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac
Step 2b: If you DO NOT HAVE any affected devices to return, please complete the business reply form, indicating you have no devices and return by one of the means listed below:
1. Email to: padpro2602@conmed.com
2. Fax to: Field Action Support Team at 315-624-3225.
3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team
If you have any questions or requests, please don't hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email padpro2602@conmed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and unique device identification (udi) information.
Acción
On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following:
Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions:
1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above.
2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned.
3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned.
4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990.
5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International.
6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.
Acción
The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following:
Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately.
Step 2a: If you HAVE inventory of any of the devices with the lot codes listed on the notice, complete the business reply form and return it with the devices to: CONMED Corporation 525 French Road Utica, NY 13502 USA Attn: Ed Kovac
Step 2b: If you DO NOT HAVE any affected devices to return, please complete the business reply form, indicating you have no devices and return by one of the means listed below:
1. Email to: padpro2602@conmed.com
2. Fax to: Field Action Support Team at 315-624-3225.
3. US mail, using enclosed postage-paid envelope, to: CONMED, 525 French Road, Utica, NY 13502; Attn: Field Action Support Team
If you have any questions or requests, please don't hesitate to contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email padpro2602@conmed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Causa
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and unique device identification (udi) information.
Acción
On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following:
Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions:
1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above.
2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned.
3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned.
4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990.
5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International.
6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and unique device identification (udi) information.
Acción
On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following:
Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions:
1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above.
2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned.
3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned.
4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990.
5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International.
6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and unique device identification (udi) information.
Acción
On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following:
Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions:
1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above.
2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned.
3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned.
4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990.
5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International.
6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, catheter - Product Code DYB
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
unknown device name - Product Code N/A
Causa
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
Acción
The firm, Cypress Medical Products, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated 11/16/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately discontinue use of any product matching the affect items; If you have product affected by this notice, a recall label must be applied to each affected convenience kit. Please contact Cypress Medical Products, LLC customer service via email at cypress.customerservice@cypressmed.com to request the number of labels required. Upon opening the kit during procedure time, please dispose of the affected Aplicare Povidone Iodine Prep Pad in accordance with your institutions policies and procedures. If you have further distributed the product, please notify your customers and provide the customer with a copy of this notification. Complete and return the Reply form via email to: Cypress Medical Products LLC, Attn: Cypress Customer Service at: cypress.customerservice@cypressmed.com, even if you have no affected product.
To ensure product availability, new orders for the affected convenience kits will be shipped with the affixed recall labels until new product is made available from the manufacturer.
If you have any questions concerning this recall, please contact Cypress Customer Service at the email: cypress.customerservice@cypressmed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Introducer, catheter - Product Code DYB
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Microscope, surgical - Product Code EPT
Causa
The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.
Acción
The customer was notified via email on about January 4, 2017. Instructions included that the scope only tips if the user has it extended all the way out and is pulling on the handles of the scope. The end user must not pull on the handles of the scope when it is extended. They were also instructed to educate personnel on this matter. For further questions, please call (314) 968-2282.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Causa
Products do not contain the central venous catheter placement procedures note or the central line insertion checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Acción
On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions:
1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory.
2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Acción
Letters dated 2/16/2018 for U.S. customers were issued via certified mail on 3/14/2018. Letters to customers outside of the U.S. were localized in conjunction with the local Philips market organizations and are in progress.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Acción
Letters dated 2/16/2018 for U.S. customers were issued via certified mail on 3/14/2018. Letters to customers outside of the U.S. were localized in conjunction with the local Philips market organizations and are in progress.