Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Pending LLM rewrite. Source: FDA_DEVICE Z-2531-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Potential for open header bag seals, compromising sterility.
The recalled product
- Product
- Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22