Moderate riskFDA DeviceClass II

Halyard Towel Six Pack recalled for non-sterilized sealed pouches

AVID Medical inadvertently distributed 224 kits of Halyard Towel Six Pack (Kit Code AMTS70-01) with sealed pouches that had not undergone validated sterilization. The affected kits were distributed nationwide, with concentration in Iowa. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All AVID Medical recalls

What to do

  1. Check your Halyard Towel Six Pack kit for Kit Code AMTS70-01 and Lot Number AMTS70-01.
  2. Do not use pouches from affected kits in sterile field applications.
  3. Contact your supplier or AVID Medical for instructions on return or replacement.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard, Towel Six Pack. Kit Code: AMTS70-01.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
224 kits
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Classification
Class II
Recall number
Z-2408-2026

In the FDA's words

Description
Halyard, Towel Six Pack. Kit Code: AMTS70-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Kit Code: AMTS70-01. UDI-DI: 10809160469972. Lot Number: AMTS70-01. Expiration Date: 9/2/2028. Distribution: US Nationwide distribution in the state of Iowa. Affected quantity: 224 kits
Hazard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

4 products in this recall

Halyard medical kits recalled for sterilization concerns

AVID Medical is recalling four Halyard kit types because sealed pouches were distributed without validated sterilization. The kits may not be sterile, and the recall includes 476 kits total, distributed in Iowa. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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Related topics

SterilityMedical devicesSold nationwideMore from FDA Device