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Recall Observatory FDA recall evidence

Device product

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Z-1338-2026

January 02, 2026

Class II

Product summary

Firm
AVID Medical, Inc.
Event
Event 98298
Status
Ongoing
Classification
Class II
Quantity
1,500 units
Official record key
device-enforcement:Z-1338-2026

Official wording

Reason: Tyvek bag seal issue which may compromise sterility of the kit.

Code information: Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028

Distribution pattern: US Nationwide distribution in the states of New Jersey.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    bag seal issue which may compromise
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    bag seal issue which may compromise sterility