Z-1978-2026 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
- 2,392 kits
Product Description
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
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: SAMM066-15. UDI-DI (Kit Lot Numbers): 10809160388495 (1561685, 1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931, 1663932).