Z-1971-2026 Class I Ongoing
FDA device recall Z-1971-2026 was initiated by AVID Medical, Inc. on March 13, 2026 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 180 kits.
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
- 180 kits
Product Description
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
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: DRCC36. UDI-DI (Kit Lot Numbers): 10809160469088 (1659651).