Halyard recall: Sterility Concern
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Why was Halyard recalled?
Potential for open header bag seals, compromising sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.
- Product
- Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 228 units
- Distribution
- US Nationwide distribution in the state of Florida.
- Recall date
- September 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)