Dressing Shldr XL recalled over sterility concerns

Recall date

March 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Breg Inc recalls Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between…

Recall number

Z-1906-2017

FDA classification

Class II

Brand / firm

Breg Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.