Z-2940-2018 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
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
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
MCDA290 MHLQ370 MHMZ270 MHSN190 MHTH950 MHTR800 MHXL900 MJAT510 MJAZ020 MJBL200 MJCV760 MJFP340 MJGC620 MJGX680 MJKN210 MJLP090 MLDF860 MHLL060 MHND620 MHPA230 MHQZ510 MHSR590 MHXJ990 MHYS090 MJDW030 MJGK930 MJGX690 MJJF710 MLBA570 MLBK460 MLCT650 MHKJ180 MHMJ970 MHPK440 MHRN870 MJBP190 MJHJ860 MLBG870