Z-1974-2026Class I

AVID Medical, Inc.

Recalling firm

AVID Medical, Inc.

Product type

Device

Status

Ongoing

Report date

2026-05-13

Distribution

US distribution to FL, IL, MO, MS, NC, NE, TX.

Firm state

Product quantity

172 kits

Initiated by

Voluntary: Firm initiated

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.

Product description

Halyard CATH LAB kit. Model Number: SACL75-01.

Code / lot 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).

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.