Organ recovery surgical packs recalled as not suitable for organ transplant
AVID Medical is recalling 52 Halyard Organ Recovery OR Packs because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The Halyard ORGAN RECOVERY OR PACK, kit code LLOF1000-17, is being recalled by AVID Medical, Inc.
The reason given in the enforcement record is that the devices are not suitable for organ transplant.
The record lists 52 units carrying UDI 10809160460726, from lot 1651709. Distribution was nationwide in the United States, in Florida, Georgia and Puerto Rico. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine the affected lot immediately and follow the firm's instructions.
The recalled product
- Product
- Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Procedure tray
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Kit Code: LLOF1000-17
- UDI : 10809160460726
- Lot No : 1651709
Distribution
Part of a larger recall action
This product is one of 3 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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Same hazard · unsuitable for use
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- CriticalOrgan recovery packs recalled as not suitable for organ transplant
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