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.
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.
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
Orthopedic tray - Product Code OJH
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.