FDAJuly 12, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

medical components inc dba medcompmedicalmedical components

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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