Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC24249...
FDA Recall #Z-2520-2025 — Class II — July 17, 2025
Product Description
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
Reason for Recall
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Recalling Firm
O&M HALYARD INC — Alpharetta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1316
Distribution
Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX.
Code Information
Model/UDI-DI/Lot(expiration): 88041-12/30680651880414/AC2424601B9(09/02/2029), 77165-06/30680651771651/AC2424902B(09/05/2029)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated