medical Class II Updated 2018-09-05

Medical Components, Inc dba MedComp recalls DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67

Recalled Product

DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67

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: MCBC900 MCBP350 MCDC900 MCGA140 MCCD760 MKAL320 MCAS020 MCCF310 MCCV750 MCCV870 MCDL720 MCDV440 MCFJ760 MKAF680
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