Z-2933-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2018
- Initiation Date
- July 12, 2018
- Termination Date
- July 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Reason for Recall
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
Distribution Pattern
Nationwide distribution; worldwide distribution.
Code Information
MCAJ510 MCAP860 MCAZ820 MCCB890 MCCJ250 MCDF160 MCDQ630 MCFF200 MCFF620 MCFK200 MCFV440 MKAK310 MCAW770 MCBW430 MCCH320 MCCJ690 MCFB450 MCFF930 MCFV450 MKAK320 MKAV210 MCAY080 MCBD600 MCBP740 MCBW440 MCCA030 MCCH330