FDA-Device2025-01-29Class II

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.
Hazard

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

Sold states
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.
Affected count
1440 units
Manufactured in
9120 Lockwood Blvd, Mechanicsville, VA, United States
Products
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2025

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