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
VA
Product quantity
2,932 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 HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Code / lot 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).
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.