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Recall Observatory FDA recall evidence

Device product

Duo-Flow XTP Straight Full Set, RMS02105 RMS02108

Z-2937-2018

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-2937-2018

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: MKAC440 MCCH440

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.