FDA Enforcement
Class II
Terminated
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Recall: Z-1901-2017
·
Reported May 10, 2017
Enforcement
- Recall Number
- Z-1901-2017
- Event ID
- 76994
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Breg Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 10, 2017
- Initiation Date
- March 30, 2017
- Classification Date
- May 1, 2017
- Termination Date
- June 23, 2017
- Address
- 2885 Loker Ave E, Carlsbad, CA, 92010-6626, United States
Description
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Reason
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Code Info
D163434
Distribution
US Nationwide Distribution