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Recall Observatory FDA recall evidence

Device product

Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108

Z-2932-2018

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-2932-2018

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: MCAW430, MCBR560, MCCX620 MCCF020 MCFK440 MKAY620

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.