AVID Medical, Inc. recalls Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131
See all recalls from AVID Medical, Inc. →Recalled Product
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Hazard / Issue
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Issued by
FDA
Affected States: FL, IL, MO, MS, NC, NE, TX
Lot/Code Info: 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).
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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