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.
Potential friction holes may affect the sterility of the product.
Acción
The firm, Vygon USA, mailed an "URGENT MEDICAL DEVICE RECALL" letter dated 2/28/2018 to affected customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: 1) Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2) Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form; 3) complete and return form via Fax to 215-672-6740 or email to: customerservice@vygonus.com including customer contact information; 4) Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5) Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up.
Distributors are instructed to: communicate the recall to customers who received the affected product by providing them a copy of the notification. Also, provide a copy of the Recall Acknowledgement and Inventory Return Form to customers.
If you have questions or concerns please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential friction holes may affect the sterility of the product.
Acción
The firm, Vygon USA, mailed an "URGENT MEDICAL DEVICE RECALL" letter dated 2/28/2018 to affected customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: 1) Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2) Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form; 3) complete and return form via Fax to 215-672-6740 or email to: customerservice@vygonus.com including customer contact information; 4) Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5) Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up.
Distributors are instructed to: communicate the recall to customers who received the affected product by providing them a copy of the notification. Also, provide a copy of the Recall Acknowledgement and Inventory Return Form to customers.
If you have questions or concerns please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential friction holes may affect the sterility of the product.
Acción
The firm, Vygon USA, mailed an "URGENT MEDICAL DEVICE RECALL" letter dated 2/28/2018 to affected customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: 1) Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2) Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form; 3) complete and return form via Fax to 215-672-6740 or email to: customerservice@vygonus.com including customer contact information; 4) Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5) Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up.
Distributors are instructed to: communicate the recall to customers who received the affected product by providing them a copy of the notification. Also, provide a copy of the Recall Acknowledgement and Inventory Return Form to customers.
If you have questions or concerns please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential friction holes may affect the sterility of the product.
Acción
The firm, Vygon USA, mailed an "URGENT MEDICAL DEVICE RECALL" letter dated 2/28/2018 to affected customers. The letter described the product, problem and actions to be taken. The Customers are instructed to: 1) Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately; 2) Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form; 3) complete and return form via Fax to 215-672-6740 or email to: customerservice@vygonus.com including customer contact information; 4) Vygon customer service will contact the customer and issue a Return Merchandise Authorization number; 5) Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up.
Distributors are instructed to: communicate the recall to customers who received the affected product by providing them a copy of the notification. Also, provide a copy of the Recall Acknowledgement and Inventory Return Form to customers.
If you have questions or concerns please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Functionality in the report sections "findings information" and "summary of measured findings" not functioning properly. the corrected values modified in the report are neither saved, nor printed, nor sent to the information system. the system will still use original values.
Acción
On 03/27/18 Firm became aware that recall was necessary
Firm initiated recall on 03/27/18 via customer information letter SY007/18/P advising that corrected values modified in the report are not save. Software patch VB20A_HF05 is being released to resolve the matter
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
Stretcher, wheeled - Product Code FPO
Causa
The operations manual and maintenance manual are missing various warnings and contain incorrect information.
Acción
On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following:
1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual.
2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com
3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form.
4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.
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
Stretcher, wheeled - Product Code FPO
Causa
The operations manual and maintenance manual are missing various warnings and contain incorrect information.
Acción
On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following:
1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual.
2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com
3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form.
4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.
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
Plate, fixation, bone - Product Code HRS
Causa
There is an error in the caddy artwork that misidentifies a specific plate and screw.
Acción
Notification letters were sent on 3/20/18. The letters instructed customers to:
We ask you to be aware of the incorrect numbers and ensure you are ordering the correct part numbers until replacement parts are available. You will be informed promptly of the availability of the replacement trays. You will be contacted to arrange return and to exchange the parts presently in your possession.
Our records indicate that you have received one or more of the trays involved. Therefore, we would ask you to reply to this memo and confirm the quantities of each tray in your possession. Your response will serve as acknowledgement of this notification and that you will act in compliance. Please reply to dschwartzbauer@EPICextremity.com.
The notification letter included photographs of products to indicate errors in labeling.
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
Trocar - Product Code DRC
Causa
Products have been packaged with the wrong trocar length type.
Acción
On March 26, 2018 CopperSurgical Inc. mailed a Medical Device Recall Notification to affected customers. Customers were instructed to discontinue the use of the affected lot number 223333 and complete an Acknowledgement and Receipt Form to schedule refund or exchanges. If customers supplied products to any other facility, they have been asked to provide the recipients a copy of the notification letter. Customers with questions may contact CopperSurgical at recall@coopersurgical.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
Plate, fixation, bone - Product Code HRS
Causa
There is an error in the caddy artwork that misidentifies a specific plate and screw.
Acción
Notification letters were sent on 3/20/18. The letters instructed customers to:
We ask you to be aware of the incorrect numbers and ensure you are ordering the correct part numbers until replacement parts are available. You will be informed promptly of the availability of the replacement trays. You will be contacted to arrange return and to exchange the parts presently in your possession.
Our records indicate that you have received one or more of the trays involved. Therefore, we would ask you to reply to this memo and confirm the quantities of each tray in your possession. Your response will serve as acknowledgement of this notification and that you will act in compliance. Please reply to dschwartzbauer@EPICextremity.com.
The notification letter included photographs of products to indicate errors in labeling.
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
Accessories, cleaning brushes, for endoscope - Product Code MNL
Causa
The products exhibit an unpleasant odor due to microbial contamination with yarrowia lipolytica.
Acción
Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following:
1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1.
2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us.
3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product.
4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.
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
Accessories, cleaning brushes, for endoscope - Product Code MNL
Causa
The products exhibit an unpleasant odor due to microbial contamination with yarrowia lipolytica.
Acción
Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following:
1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1.
2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us.
3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product.
4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.
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
Accessories, cleaning brushes, for endoscope - Product Code MNL
Causa
The products exhibit an unpleasant odor due to microbial contamination with yarrowia lipolytica.
Acción
Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following:
1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1.
2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us.
3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product.
4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.
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
Accessories, cleaning brushes, for endoscope - Product Code MNL
Causa
The products exhibit an unpleasant odor due to microbial contamination with yarrowia lipolytica.
Acción
Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following:
1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1.
2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us.
3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product.
4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.
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
Accessories, cleaning brushes, for endoscope - Product Code MNL
Causa
The products exhibit an unpleasant odor due to microbial contamination with yarrowia lipolytica.
Acción
Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following:
1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1.
2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us.
3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product.
4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.
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
Accessories, cleaning brushes, for endoscope - Product Code MNL
Causa
The products exhibit an unpleasant odor due to microbial contamination with yarrowia lipolytica.
Acción
Notification letters were distributed on 3/21/18. The letters instructed customers to perform the following:
1. Immediately quarantine, and discontinue the use or distribution of First Step EP-3, EP-4, EP-6, 4" Button Brush EP-4B; Travel Kit TK200(W); and Draco Enzymatic Deep-Cleaning Pad HY0305Z with the referenced lot numbers specified in Table1.
2. Determine if any stock of the with the reference lot numbers specified in Table 1 remains in your inventory. We ask that you discard the product at your facility and document the quantity discarded on the form. Otherwise, we can issue you a Return Goods Authorization, call tag and/or Fed EX/UPS account number to have the product returned back to us.
3. Please complete the attached form and return to Cygnus Medical as indicated as soon as possible. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product.
4. Please notify any of your customers who may have received lots with the referenced lot numbers specified in Table 1 with the letter provided. Your assistance is appreciated and necessary.
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.
Products have been packaged with an incorrect product size.
Acción
On March 26, 2018 CooperSurgical mailed medical device recall notification letters to affected customers. Customers were instructed to: please discontinue use of any of the lots listed in the table above and complete the attached Acknowledgement and Receipt Form to schedule refund or exchange. If you have supplied or transferred any potentially affected product to another facility or organization, please let them know of the recall by providing a copy of this letter. If you have any further questions, please feel free to contact CooperSurgical at recall@coopersurgical.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.
When a user switches on mr1100 receiver, even though the battery was fully charged, the led was displayed as orange color due to momentary drop of battery voltage.
Acción
Intromedic representatives visited hospitals with the affected products after the first awareness of the problem in order to explain the corresponding issue to our distributor in USA and gave them training on how to check the software before and after the software update.
Firm revisited the hospitals in which the software was not conducted by our distributor and carried out the software update since Nov 13th, 2017.
The software update was not made immediately as we believe that the reoccurrence possibility of this issue is very low since have not received any other report of the issue from USA and other countries, and the receiver works fine after it is turned off and on again.
Some of the hospitals visited refused to conduct software update while being aware of the issue as they were not encountered with the issue.
The remaining hospitals in which software update is not conducted will be visited and software update will be conducted by firm's distributor by April.
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
Automated urinalysis system - Product Code KQO
Causa
The strip provider modules (spm) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
Acción
The recalling firm, Beckman Coulter/IRIS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated dated 3/26/2018 via email on 3/29/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
-Follow the on-board strip stability claims per Table 1 to determine the frequency at which the strips need to be changed.
-Whenever the Strip Provider Module is accessed (i.e., opened or when loading strips), remove and discard the remaining on-board strips and desiccant before replenishing.
-It is suggested that for the tests performed since the installation of the iChemVELOCITY/SPM housing assembly, consult with your Laboratory Director to determine whether a retrospective review of results is clinically warranted.
-Complete and return the CUSTOMER RESPONSE FORM within 10 days by email to: Regulatory.Notifications@beckman.com, Please include FA-33476 iChemVELOCITY Automated Urine Chemistry System in e-mail subject field or by mail to:Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06
11800 S.W. 147th Avenue, P O BOX 169015, Miami, FL 33116-9015.
-Beckman Coulter will contact you by phone to schedule a site visit for replacing the SPM on your instrument.
-Beckman Coulter will be implementing process improvements to prevent this issue from recurring.
If you have any questions regarding this notice, please contact:
- From our website: http://www.beckmancoulter.com
- By phone: call 800-854-3633 in the United States and Canada. ¿
-Outside the United States and Canada, contact your local Beckman Coulter representative.
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
Acción
The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions:
"Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions.
For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice.
Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
Acción
The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions:
"Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions.
For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice.
Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
Acción
The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions:
"Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions.
For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice.
Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
Acción
The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions:
"Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions.
For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice.
Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
Acción
The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions:
"Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions.
For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice.
Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."
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
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
The patient id card packaged with the powerport clearvue implantable port with smooth septum contains incorrect port flushing instructions.
Acción
The firm initiated the recall by letter on 02/08/2018. The letter explained the problem and the products involved and requested the following actions:
"Please check all inventory locations within your institution for affected product code / lot number combinations listed in the field correction notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of this field correction notice, and forward these instructions.
For any identified product on your shelves, please replace the products Patient ID Card with the corrected Patient ID Card enclosed with this field correction notice.
Enclosed with this field correction notice is a Patient Communication Packet that contains one patient letter, one corrected Patient ID Card, and one POWERPORT¿ Patient Guide. Please contact all patients that have received any product listed in this field correction notice and provide them with the Patient Communication Packet."