Halyard pain packs shipped without validated sterilization in Iowa
Halyard Pain Packs, kit code AMPK48-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 120 kits affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where surgical kits were distributed without validated sterilization, a risk of harm with no injuries reported in the source.
Plain-English summary
The Halyard Pain Pack, kit code AMPK48-01, UDI-DI 10809160472798, is being recalled. The action covers 120 kits in lot 334669, with an expiration date of 8/27/2028.
The stated reason is the inadvertent distribution of sealed pouches that had not undergone validated sterilization. The FDA classified the action as Class II.
Distribution was within the United States, in Iowa. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected kits using the kit code, UDI-DI and lot number above, quarantine them, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Halyard, Pain Pack. Kit Code: AMPK48-01.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical kit
- Affected units
- 120
Distribution
Part of a larger recall action
This product is one of 4 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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