Halyard towel six packs shipped without validated sterilization in Iowa
Halyard Towel Six Packs, kit code AMTS70-01, are being recalled because sealed pouches that had not undergone validated sterilization were inadvertently distributed. 224 kits affected.
What this means for you
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 Towel Six Pack, kit code AMTS70-01, UDI-DI 10809160469972, is being recalled. The action covers 224 kits, with an expiration date of 9/2/2028.
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 expiration date above, quarantine them, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Halyard, Towel Six Pack. Kit Code: AMTS70-01.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical kit
- Affected units
- 224
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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