Halyard Organ Recovery Kit Recalled Due to Device Unsuitability
AVID Medical recalls 132 units of the Halyard ORGAN RECOVERY OR PACK (Kit Code: LLOG1000-15) due to device unsuitability for organ transplant. The recalled units were distributed nationwide in Florida, Georgia, and Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The U.S. Food and Drug Administration classified this as a Class I recall, which requires a minimum severity score of 4 per rubric guidelines. No deaths or reported serious injuries are documented in the source material.
Plain-English summary
AVID Medical, Inc. is recalling 132 units of the Halyard ORGAN RECOVERY OR PACK (Kit Code: LLOG1000-15). The recalled devices have lot numbers 1632138 and 1648393, with UDI 10809160432679.
The devices are not suitable for organ transplant. The U.S. Food and Drug Administration has classified this as a Class I recall, the most serious classification for medical devices.
The recalled units were distributed nationwide in Florida, Georgia, and Puerto Rico.
Health care providers and transplant centers using the recalled devices should stop using them immediately and contact AVID Medical, Inc. for instructions on return or proper disposal.
The recalled product
- Product
- Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- transplant-failure-risk
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: LLOG1000-15
- UDI: 10809160432679
- Lot No: 1632138 & 1648393.
Distribution
Distributed nationwide across the United States.
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