Halyard Mini Plus Kit recalled as unsuitable for organ transplant
AVID Medical is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08) because the devices are not suitable for organ transplant procedures. The recall affects 380 units distributed in Florida, Georgia, and Puerto Rico.
From the FDA notice · Read the official notice ↗ · All AVID Medical recalls
What to do
- Stop using this kit immediately if you have it in your facility.
- Check your inventory for Kit Code JACK097-08 and Lot No. 1654185.
- Contact your supplier or AVID Medical for instructions on return or replacement.
- If this kit was already used in an organ transplant procedure, contact your medical director or the FDA.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 380 units
- Illnesses reported
- None reported
- Manufactured in
- 9000 Westmont Dr, Toano, VA, United States
- Classification
- Class I
- Recall number
- Z-1002-2026
In the FDA's words
- Description
- Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 Devices are not suitable for organ transplant. Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185. Distribution: US Nationwide distribution in the states of FL, GA and Puerto Rico. Affected quantity: 380 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.
- Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.Z-1000-2026 · 132 units
- Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.Z-1001-2026 · 52 units
- Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 (this page)Z-1002-2026 · 380 units
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