Moderate riskFDA DeviceClass II

Halyard Eye Bag Pack recalled for non-sterilized sealed pouches

AVID Medical, Inc. distributed 60 kits of Halyard Eye Bag Pack (Kit Code UIEB48-01) with sealed pouches that did not undergo validated sterilization. The affected kits were distributed nationwide in Iowa. No injuries have been reported.

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

What to do

  1. Check if you have Kit Code UIEB48-01 with lot number UIEB48-01 and expiration date 8/7/2028.
  2. Stop using the product and contact AVID Medical, Inc. or your supplier for instructions on return or replacement.
  3. Do not use non-sterilized medical pouches.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
60 kits
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Classification
Class II
Recall number
Z-2410-2026

In the FDA's words

Description
Halyard, Eye Bag Pack. Kit Code: UIEB48-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Kit Code: UIEB48-01. UDI-DI: 10809160484098. Lot Number: UIEB48-01. Expiration Date: 8/7/2028. Distribution: US Nationwide distribution in the state of Iowa. Affected quantity: 60 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