Class II
Medical Device Recall: Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
O&M HALYARD, INC. · November 26, 2024
Reason for Recall
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
1440 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0983-2025
Status: ongoing
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