Device recall enforcement reports

Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.

AVID Medical, Inc. · A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.

Class IIOngoingZ-0283-2027
Status
Ongoing
City
Toano
State
VA
Country
United States
Classification
Class II
Product type
Devices
Event ID
99968
Recalling firm
AVID Medical, Inc.
Address 1
9000 Westmont Dr
Postal code
23168-9351
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
E-Mail
Distribution pattern
US Nationwide distributor in the state of Arizona.
Recall number
Z-0283-2027
Product description
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
Product quantity
80 kits
Reason for recall
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Recall initiation date
20260908
Center classification date
20261022
Report date
20261028
Code info
Model/Catalog Number: SOAH30. UDI-DI: 10809160520246. Lot Code: Lot Numbers: 1705826, 1705827. Expiration Date: 1/31/2028.
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.