HALYARD Laparotomy Surgical Pack Recalled for Additive Residue Contamination
O&M HALYARD is recalling HALYARD Laparotomy Packs due to elevated residues of anti-block/slip additives found in the sterile packaging. These surgical instruments were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving elevated residues of manufacturing additives in sterile surgical instrument packaging. While no injuries or illnesses have been reported, contamination residues present a risk of harm if they contaminate the sterile surgical field during medical procedures.
Plain-English summary
O&M HALYARD, Inc. is recalling HALYARD Laparotomy Packs (Model 88231) due to elevated residues of anti-block/slip additives in the sterile packaging. Laparotomy packs are sterile surgical instrument kits used during abdominal surgery procedures.
The anti-block/slip additives are used during manufacturing to prevent materials from sticking together. Elevated levels of these residues were found in the sterile packaging, which could potentially contaminate the sterile surgical field when the pack is opened and used during medical procedures.
Approximately 1,440 units were distributed nationwide to healthcare facilities in Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Tennessee, Texas, Virginia, and Wisconsin. The affected lot is AC2335502D with an expiration date of December 28, 2021.
Healthcare facilities that received these packs should discontinue use and contact O&M HALYARD for instructions on returning affected units or obtaining replacements.
The recalled product
- Product
- Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
- Manufacturer
- O&M HALYARD, INC.
- Category
- Medical Device — Surgical Pack
- Affected units
- 1,440
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model No 88231
- UDI-DI: 30680651882319
- Lot Number: AC2335502D
- Exp Date 21-12-28
Distribution
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