Z-1974-2026 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
- 172 kits
Product Description
Halyard CATH LAB kit. Model Number: SACL75-01.
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: SACL75-01. UDI (Kit Lot Numbers): (01)20809160481377(17)280520(10)341730(30)004(241)UINR44-01 (341730), (01)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742), (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855), (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863).