FDAFDA · Food and drugs·Recall number Z-1906-2017
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.
Published May 10, 2017 · Recall initiated: March 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Breg Inc
- Distributor
- US Nationwide Distribution
- Lot
- D163544
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.