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Parker Quality & Compliance

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Device recall

Halyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21.

FDA recall source

Recall number
Z-0358-2027
Event id
99964
Status
Open, Classified
FDA classification
Class II
Recalling firm
AVID Medical, Inc.
Posted
Nov 5, 2026
Initiated
Sep 8, 2026
Product code
LRO
Device type
General Surgery Tray
Reason
Shelf label of kit is mislabeled as "Extremity" instead of "Arthroscopy Pack."
Root cause
Process control
Quantity
17 kits
Code info
Model/Catalog Number: SAMM014-21. UDI-DI: 10809160515600. Lot Number: 1698318. Expiration Date: 12/3/2026.
Distribution
US Nationwide distribution in the state of Texas.
Location
Toano, VA