AVID Medical, Inc. recalls Halyard
Reason for recall
Potential for open header bag seals, compromising sterility.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kitUDI 10809160363256.Model Number2 affected lots16463811/31/2028
What the firm is doing
Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.
DistributionShow detailsHide
US Nationwide distribution in the state of Florida.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2531-2025
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find AVID Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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