Z-1975-2026 Class I Ongoing

Recalled by AVID Medical, Inc. — Toano, VA

Recall Details

Product Type
Devices
Report Date
May 13, 2026
Initiation Date
March 13, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,932 kits

Product Description

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

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 Pattern

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

Code Information

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).