Recall Weekly
Serious riskFDA DeviceClass I

Halyard organ recovery pack recalled, not suitable for organ transplant

Halyard's ORGAN RECOVERY OR PACK (Kit Code LLOF1000-17) is not suitable for organ transplant procedures. The FDA has classified this as a Class I recall, the most serious type. A total of 52 units were distributed in Florida, Georgia, and Puerto Rico.

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

What to do

  1. Stop using Kit Code LLOF1000-17 immediately if you have it in your facility
  2. Contact your supplier or Halyard for instructions on return or disposal
  3. Verify the kit code and UDI (10809160460726) or lot number (1651709) before use
  4. Notify your transplant team or procurement coordinator if you received this kit
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
52 units
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Classification
Class I
Recall number
Z-1001-2026

In the FDA's words

Description
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. Devices are not suitable for organ transplant. Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709 Distribution: US Nationwide distribution in the states of FL, GA and Puerto Rico. Affected quantity: 52 units
Hazard
Devices are not suitable for organ transplant.

3 products in this recall

Halyard organ recovery packs and kits recalled for transplant unsuitability

AVID Medical is recalling three Halyard kits, totaling 564 units, because the devices are not suitable for organ transplant. The kits were distributed nationwide, with US distribution in Florida, Georgia, and Puerto Rico. No injuries have been reported.

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

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