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
Implant, endosseous, root-form - Product Code DZE
Causa
Information specific to the 3.7 mmd and 4.1 mmd trabecular metal zimmer dental implants was omitted from the latest revision of the applicable ifu in the indications, contraindications, and precautions sections.
Acción
Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form.
It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records.
For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Information specific to the 3.7 mmd and 4.1 mmd trabecular metal zimmer dental implants was omitted from the latest revision of the applicable ifu in the indications, contraindications, and precautions sections.
Acción
Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form.
It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records.
For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Information specific to the 3.7 mmd and 4.1 mmd trabecular metal zimmer dental implants was omitted from the latest revision of the applicable ifu in the indications, contraindications, and precautions sections.
Acción
Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form.
It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records.
For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Information specific to the 3.7 mmd and 4.1 mmd trabecular metal zimmer dental implants was omitted from the latest revision of the applicable ifu in the indications, contraindications, and precautions sections.
Acción
Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form.
It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records.
For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Information specific to the 3.7 mmd and 4.1 mmd trabecular metal zimmer dental implants was omitted from the latest revision of the applicable ifu in the indications, contraindications, and precautions sections.
Acción
Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form.
It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records.
For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Information specific to the 3.7 mmd and 4.1 mmd trabecular metal zimmer dental implants was omitted from the latest revision of the applicable ifu in the indications, contraindications, and precautions sections.
Acción
Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form.
It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records.
For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Information specific to the 3.7 mmd and 4.1 mmd trabecular metal zimmer dental implants was omitted from the latest revision of the applicable ifu in the indications, contraindications, and precautions sections.
Acción
Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form.
It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records.
For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
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
Implant, endosseous, root-form - Product Code DZE
Causa
Information specific to the 3.7 mmd and 4.1 mmd trabecular metal zimmer dental implants was omitted from the latest revision of the applicable ifu in the indications, contraindications, and precautions sections.
Acción
Zimmer sent an Urgent Device Correction letter dated January 6, 2016 to all affected customers.. The letter identified the affected product, problem and actions to be taken. Customers were asked to do the following; review the notice and check inventory for the affected units, ff they wish to keep the product familiarize themselves with the Technical Bulletin information, if they wish to return the affected product call Zimmer Dental Customer Service at 1-800-854-7019 to obtain a Return Authorization Number and to setup a FedEx pick-up to return the products, and complete Attachment 1, the Business Reply Form.
It was requested that customers maintain a copy of the noticeand a signed copy of Attachment 1 for your records.
For assistance or any other questions contact Zimmer Dental Customer Service at 1-800-854-7019. Customer Service is available 7:00am to 5:00pm (Pacific), Monday through Friday.
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
Laryngoscope, rigid - Product Code CCW
Causa
The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when glidescope titanium su laryngoscope blades are in use. video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
Acción
The firm, Verathon, began mailing the "URGENT: MEDICAL DEVICE RECALL"
GLIDESCOPE VIDEO LARYNGOSCOPE TITANIUM SINGLE-USE BLADES letter to their consignees on January 29, 2016. The letter describes the product, problem and actions to be taken.
Verathon will instruct the company's foreign distributors to communicate the Customer Recall Letter to their international customers.
Verathon has contracted with a business services company, Stericycle, to coordinate the initial consignee communications in the United States, Australia and Canada. Stericycle will send the Customer Recall Letters, and conduct consignee follow-up communications for return of the Recall Response Forms.
Verathon will replace all affected GlideScope Titanium Single Use (SU) blades that remain in your facility's inventory with new product that has been passed the enhanced screening test for video flickering.
Customers were advised to take the following actions:
-Fill out the attached Recall Response Form and return it to Verathon by fax (888) 943-5170, or email, verathon5165@stericycle.com. Please return the form even if you do not have any blades subject to the recall.
If consignees need to expedite a product replacement contact Verathon representative or Verathon Customer Care at (800) 331-2313 (U.S. and Canada). The firm has live agent support Monday through Friday from 8:00am to 5:00pm Eastern Time. Consignees can also send email to CCTechSupport@verathon.com.
Consignees who have any questions about this Product Recall, please contact Verathon representative or call (888) 943-4207 (U.S. and Canada) or send email to verathon5165@stericycle.com.
Please report any suspected malfunction or adverse event related to any GlideScope Video Laryngoscope devices to Verathon Customer Care at the telephone numbers above and to FDA's MedWatch Program (1-800-FDA-1088 or www.fda.gov/medwatch).
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
System, x-ray, angiographic - Product Code IZI
Causa
The use of allura xper, allura clarity, allura cv, allura centron and uniq systems regarding live images and still images can lead to still images being interpreted as live images.
Acción
The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt.
If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
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
Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
Causa
Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Acción
Customer notification letters were sent on 01/05/2016.
Customers were asked to not use the affected product, or further distribute it. Customers were asked to check all inventory locations for the affected product code, lot number combination listed. If customers further distributed any of the product they are requested to contact that location, advise them of the recall, and forward the listed instructions. The letter states to remove all identified product from the shelves.
If no affected product is going to be returned the firm states to complete and return the attached form stating so.
If customers have product it is requested that they also complete the attached form, and state the quantities and lot numbers in stock. The letter requests that customers call the firm's Recall Coordinator, Raye Seisinger, at 1-800-321-4254, option #2 ext. 2501 (M-F 6am to 3pm MST) or email raye.seisinger@crbard.com. Once all information has been verified the customer will be issued a Return Authorization or Consignment Recall Number to facilitate the expedient return of the product. The firm will provide replace product for returned product.
Fax the attached form to the firm at 1-800-994-6772. If the customer cannot fax the firm they request that the Recall Coordinator be contact and provided the information verbally.
The letter states a mailing label is enclosed to return the affected product. Customers are requested to amek the package as "recalled product" and include the XC or XH number. All products should be returned to the following shipping address:
Bard Peripheral Vascular, Inc.
1415 W. 3rd St.
Tempe, AZ 85281
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
Accelerator, linear, medical - Product Code IYE
Causa
In ds/us proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. this can result in an incorrect dose calculation.
Acción
Philips sent an "Urgent Medical Device Correction" letter dated 16-DEC-2015 to affected customers. The letter described the Affected Products, Problem Description, Hazard Involved, How to Identify Affected Products, Action to be Taken by Customer / User, Actions Planned by Philips and Further Information and Support (contact Philips Customer Care Solutions Center at 1-800-722-9377 ).
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Cesarean section kit - Product Code OHM
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Obstetrical kit - Product Code OKV
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.
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
Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Causa
A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Acción
Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customer was provided the following instructions:
1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users.
2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users.
For any questions the customers is instructed to contact the firm.
For questions regarding this recall call 520-882-7794.