Halyard HEART CATH SELF REGIONAL kit syringe adapter disconnection hazard
AVID Medical is recalling the Halyard HEART CATH SELF REGIONAL kit (Model SELF131-05) because the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
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 FDA classified this as a Class I recall of a cardiac catheterization device. The potential for component disconnection during use of a critical cardiac procedure represents a serious risk of harm and meets the threshold for Severe (Class I medical device recalls with risk of injury).
Plain-English summary
AVID Medical, Inc. is recalling the Halyard HEART CATH, SELF REGIONAL kit, Model Number SELF131-05, distributed in the United States to Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas.
The syringe rotating adaptor on this cardiac catheterization kit may unwind during use. This unwinding can result in a loose connection or complete disconnection between the syringe and manifold, potentially compromising the integrity of the catheterization procedure.
Approximately 2,932 kits are affected by this recall. The affected kit lot numbers are: 1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, and 1671950.
Healthcare facilities and providers should stop using the affected kits immediately. Contact AVID Medical, Inc. for instructions on returning the recalled products or obtaining replacement kits.
The recalled product
- Product
- Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- disconnection-hazard
- device-failure
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 (16)
- Model Number: SELF131-05. UDI-DI (Kit Lot Numbers): 10809160408650 (1611688
- 1611689
- 1618351
- 1621441
- 1627930
- 1635908
- 1644501
- 1646021
- 1651957
- 1654887
- 1656582
- 1656581
- 1659713
- 1670884
- 1670885
- 1671950).
Distribution
Distributed in 7 states:
- FL
- IL
- MO
- MS
- NC
- NE
- TX