medical Class II Updated 2018-09-05

Medical Components, Inc dba MedComp recalls SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T400

Recalled Product

SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424

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: MCBH160 MCCJ940 MKAG230 MKAS240 MBZV560 MCAR110 MCBM700 MCBZ130 MCCK670 MCCV840 MCDC320 MCDH160 MCDP900 MCFB210 MCFN490 MCFP330 MCFQ160 MCFX190 MKAF070 MKAJ840 MKAS430 MKAZ840 MBZB490 MCAD070 MCBB940 MCBH000 MCBN030 MCBT690 MCCK250 MCCP870 MCDK690 MCDP260 MCFG470 MCFV940 MKAF420 MKAJ850 MKAP270 MKAT230 MCAK690 MCBD150
View official government recall

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