AVID Medical Recalls Halyard Anterior Hip Packs Due to Sterilization Error
AVID Medical is recalling 80 Halyard Anterior Hip Packs because a non-sterile component was not properly sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source does not report any illnesses, injuries, or deaths.
Plain-English summary
AVID Medical, Inc. is recalling 80 kits of the Halyard Anterior Hip Pack, Model/Catalog Number SOAH30. The recall was initiated because a non-sterile component was incorrectly placed outside of the sterile barrier and was not subjected to ethylene oxide (EO) sterilization as required by the kit specifications.
The affected products are identified by Lot Numbers 1705826 and 1705827, with an expiration date of 1/31/2028. The UDI-DI for the product is 10809160520246. The products were distributed to a US Nationwide distributor in the state of Arizona.
Healthcare facilities and consumers should stop using these specific kits and contact AVID Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 80
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1705827. Expiration Date: 1/31/2028.
Distribution
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