MEDLINE INDUSTRIES, LP - Northfield recalls DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.

Recall date

November 6, 2024

Source

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

Recall number

Z-0719-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

US Nationwide. Canada.

Why it was recalled

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

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

What was recalled

DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures.