Medical device recalls Moderate risk

O&M HALYARD, INC. recalls Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description…

Recall date
November 26, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0983-2025
FDA classification
Class II
Brand / firm
O&M HALYARD, INC.
Sold / distributed
US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS, LA, MI, MN, MO, NC, NE, NY, TN, TX, VA, WI.

Why it was recalled

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

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

What was recalled

Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A

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