AVID Medical, Inc.: Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX. Quantity: 2,932 kits 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).

UPC codes

10809160408650

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.