FDA recall Z-1973-2026

AVID Medical, Inc. · Class I · device

Product

Halyard CATH LAB kit. Model Number: SACL75AM.

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.

Key facts

Status
Ongoing
Initiation date
2026-03-13
Report date
2026-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Toano, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1973-2026