Halyard TRANSPORT BAG KIT recalled for potential sterility compromise due to Tyvek seal defect
Halyard TRANSPORT BAG KIT (Kit Code LIFE0080-01) may have a defective Tyvek bag seal that could compromise the sterility of the kit. The issue affects approximately 1,500 units distributed in New Jersey. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All AVID Medical recalls
What to do
- Stop using the affected kit immediately if you have Lot Number 1650056 (Expiration 07/24/2028)
- Contact your supplier or Halyard for instructions on return or replacement
- Do not use the kit for transport if the seal appears compromised or damaged
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 1,500 units
- Illnesses reported
- None reported
- Manufactured in
- 9000 Westmont Dr, N/A, Toano, VA, United States
- Classification
- Class II
- Recall number
- Z-1338-2026
In the FDA's words
- Description
- Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. Tyvek bag seal issue which may compromise sterility of the kit. Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028 Distribution: US Nationwide distribution in the states of New Jersey. Affected quantity: 1,500 units
- Hazard
- Tyvek bag seal issue which may compromise sterility of the kit.
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