Z-1975-2026 Class I Ongoing
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).