Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Reported: January 29, 2025 Initiated: November 26, 2024 #Z-0983-2025
Product Description
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Reason for Recall
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Details
- Recalling Firm
- O&M HALYARD, INC.
- Units Affected
- 1440 units
- 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.
- Location
- Mechanicsville, VA
Frequently Asked Questions
What product was recalled? ▼
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A. Recalled by O&M HALYARD, INC.. Units affected: 1440 units.
Why was this product recalled? ▼
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2025. Severity: Moderate. Recall number: Z-0983-2025.
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