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Serious riskFDA DeviceClass I

Halyard organ recovery pack kit recalled, not suitable for transplant

Halyard ORGAN RECOVERY OR PACK (Kit Code LLOG1000-15) devices have been found to be unsuitable for organ transplant use. The FDA has issued a Class I recall affecting 132 units distributed in Florida, Georgia, and Puerto Rico. No injuries have been reported.

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

What to do

  1. Stop using affected kits immediately if your facility has Lot No. 1632138 or 1648393
  2. Contact your supplier or Halyard Medical for instructions on return or disposal
  3. Verify your kit's lot number against the recall notice before use
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
132 units
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Classification
Class I
Recall number
Z-1000-2026

In the FDA's words

Description
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. Devices are not suitable for organ transplant. Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393. Distribution: US Nationwide distribution in the states of FL, GA and Puerto Rico. Affected quantity: 132 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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