Safety Alert: Class II: Potential for open header bag seals, compromising sterility.
healthClass IIRecalled on Sep 17, 2025
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
🔢 228 units
Sold At: AVID Medical, Inc.(US Nationwide distribution in the state of Florida.)
Recall #: FDA-DEVICE-Z-2531-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.
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Summary
Potential for open header bag seals, compromising sterility.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact AVID Medical, Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.