Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between…

Is this the product you have?

• Dressing M/U XL
• P/N 02344 Product UsageThese 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

Lot codes and dates

• • D163474
  • D163544

Amount recalled

2,609 units total

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

• Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used…
• Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as…
• Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used…
• Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as…
• Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used…
• Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an…
• If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile…

Where it was sold

• Nationwide

Why it was recalled

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

This product could cause temporary or reversible health problems — stop using it.