FDA recall Z-0983-2025

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2024-11-26

Report date

2025-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mechanicsville, VA, United States

Primary source

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