Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Descript
Summary
The FDA issued a Class II for Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 by O&M HALYARD, INC.. Reason: Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging..
Details
Source
Device Recall
External ID
Z-0983-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
Product Description
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Lot/Code Info: Model No 88231; UDI-DI: 30680651882319; Lot Number: AC2335502D; Exp Date 21-12-28
Quantity Affected: 1440 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-26
Company
Mechanicsville, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
O&M HALYARD, INC. has 24 FDA actions in our database, including 8 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (O&M HALYARD, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does O&M HALYARD, INC. have FDA actions?
O&M HALYARD, INC. has 24 FDA actions in our database, including 8 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0983-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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