Device product
Dressing Rect L, P/N 02428 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.
Z-1903-2017
Product summary
- Firm
- Breg Inc
- Event
- Event 76994
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,609 units total
- Official record key
device-enforcement:Z-1903-2017
Official wording
Reason: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Code information: D163474, D163544
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.