Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
FDA device recall Z-2531-2025 · posted 2025-09-05 · Open, Classified
Recall details
- Recalling firm
- AVID Medical, Inc.
- Reason for recall
- Potential for open header bag seals, compromising sterility.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 228 units
- Distribution
- US Nationwide distribution in the state of Florida.
- Date initiated
- 2025-08-04
- Date posted
- 2025-09-05
- Location
- Toano, VA
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