Recall Z-0983-2025— O&M HALYARD, INC.

Name: FDA recall Z-0983-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-26

Class II · Ongoing

Class II FDA medical device recall by O&M HALYARD, INC., initiated 2024-11-26. It names one FDA 510(k) clearance: K083234. Product: Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A. Reason: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging..

Recalling firm: O&M HALYARD, INC.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-26
Firm location: Mechanicsville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K083234 — KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100Kimberly-Clark Corp.·cleared 2009-03-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.