Recall Weekly
Moderate riskFDA DeviceClass II

Halyard Drape Pack (Kit LMDP36-01) recalled for unsterilized pouches

Halyard Drape Pack kits (Code LMDP36-01) were distributed without proper sterilization validation. Approximately 72 kits shipped with sealed pouches that had not undergone the required sterilization process. These kits were distributed nationwide and in Iowa.

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

What to do

  1. Check if you have Halyard Drape Pack Kit Code LMDP36-01, Lot LMDP36-01, with expiration 9/10/2028
  2. Do not use affected kits for sterile procedures
  3. Contact AVID Medical, Inc. or your supplier for return or replacement instructions
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard, Drape Pack. Kit Code: LMDP36-01.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
72 kits
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Classification
Class II
Recall number
Z-2409-2026

In the FDA's words

Description
Halyard, Drape Pack. Kit Code: LMDP36-01. Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Kit Code: LMDP36-01.UDI-DI: 10809160479148. Lot Number: LMDP36-01. Expiration Date: 9/10/2028 Distribution: US Nationwide distribution in the state of Iowa. Affected quantity: 72 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