medical Class II Updated 2018-09-05

Medical Components, Inc dba MedComp recalls Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter i

Recalled Product

Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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