Home / Recalls / Medical Devices
Breg Inc recalls Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier betwe
Recalled May 10, 2017 · FDA recall Z-1906-2017 · Breg
Hazard
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile. · FDA Class II
Units
2,609 units total
Sold at
US Nationwide Distribution
Description
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Product
Dressing Shldr XL, P/N 04918 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.
Manufacturer(s)
Breg Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →