FDA-Device2026-02-18Class IIPACKAGING DEFECT
Halyard TRANSPORT BAG KIT recalled for potential sterility compromise due to Tyvek seal defect
OTHERNationwide distribution
Stop using Halyard TRANSPORT BAG KIT
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.
- 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
Hazard
Tyvek bag seal issue which may compromise sterility of the kit.
Sold states
US Nationwide distribution in the states of New Jersey.
Affected count
1,500 units
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2026More AVID Medical, Inc. recalls
- FDA-Device2026-06-17Halyard Towel Six Pack recalled for non-sterilized sealed pouches
- FDA-Device2026-06-17Halyard Pain Pack Kit recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches
- FDA-Device2026-06-17Halyard Eye Bag Pack recalled for non-sterilized sealed pouches
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