Device product
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Z-0983-2025
Product summary
- Event
- Event 95920
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1440 units
- Official record key
device-enforcement:Z-0983-2025
Official wording
Reason: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Code information: Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28
Distribution pattern: 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.
Derived failure modes
-
Unknown
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.