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Recall Observatory FDA recall evidence

Device product

Halyard, Drape Pack. Kit Code: LMDP36-01.

Z-2409-2026

April 30, 2026

Class II

Product summary

Firm
AVID Medical, Inc.
Event
Event 99021
Status
Ongoing
Classification
Class II
Quantity
72 kits
Official record key
device-enforcement:Z-2409-2026

Official wording

Reason: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Code information: Kit Code: LMDP36-01.UDI-DI: 10809160479148. Lot Number: LMDP36-01. Expiration Date: 9/10/2028

Distribution pattern: US Nationwide distribution in the state of Iowa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inadvertent distribution of sealed pouches that had not undergone validated sterilization.