United StatesThe recalled products are Halyard ORGAN RECOVERY OR PACK (Kit Code LLOG1000-15, UDI 10809160432679, Lot Nos. 1632138 & 1648393), Halyard ORGAN RECOVERY OR PACK (Kit Code LLOF1000-17, UDI 10809160460726, Lot No. 1651709), and Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08, UDI 10809160462829, Lot No. 1654185). AVID Medical, Inc. is recalling these devices because they are not suitable for organ transplant; the recall is ongoing and the units were distributed in Florida, Georgia and Puerto Rico.
What's being recalled
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Recalling firm: AVID Medical, Inc., Toano, VA, United States.
How to identify it
Kit Code: LLOG1000-15; UDI: 10809160432679; Lot No: 1632138 & 1648393. Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709 Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
The hazard
Devices are not suitable for organ transplant.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of FL, GA and Puerto Rico.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)