AVID Medical, Inc.: Halyard CATH LAB kit. Model Number: SACL75-01.

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: 172 kits Lot/code info: Model Number: SACL75-01. UDI (Kit Lot Numbers): (01)20809160481377(17)280520(10)341730(30)004(241)UINR44-01 (341730), (01)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742), (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855), (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863).

UPC codes

20809160481377

Source

Official record: FDA (Device enforcement) ↗

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