Safety Alert: Class II: Potential for open header bag seals, compromising sterility.
healthClass IIRecalled on Sep 17, 2025
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
🔢 57 units
Sold At: AVID Medical, Inc.(US Nationwide distribution in the state of Florida.)
Recall #: FDA-DEVICE-Z-2530-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
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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.