FDA-Device2026-02-18Class II

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

AVID Medical, Inc.
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-1338-2026

Original summary

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

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