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Recall Observatory FDA recall evidence

Device product

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

Z-2933-2018

July 12, 2018

Class II

Product summary

Firm
Medical Components, Inc dba MedComp
Event
Event 80581
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2933-2018

Official wording

Reason: 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.

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

Distribution pattern: Nationwide distribution; worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.