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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 2,932
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
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
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