Reported Sep 5, 2018 · Terminated
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET,…
Medical Components, Inc. dba MedComp
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medical Components, Inc dba MedComp · 1499 Delp Dr · Harleysville, PA · 19438-2936
Is this the product you have?
- DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID; DOUBLE LUMEN CATHETER WITH CURVED EXTENSIONS (CATHETER ONLY), XTP114IJC=, XTP116IJC=, DOUBLE LUMEN IJ CATHETER SET, XTP114IJS=, XTP115IJS=, XTP116IJS=, XTP116IJS=JO, DOUBLE LUMEN CATHETER SET, XTP114MT= DUO-FLOW DOUBLE LUMEN CATHETER, XTP116CT, INTERNAL JUGULAR CATHETER SET, XTP96IJS= (additional product codes/catalog numbers in attached spreadsheet)
- Lot codes and dates
710 of 710 codes
MBZV810MCFG890MCAC560MCBD000MCBW980MCCL620MCCP130MCDV260MCDZ790MCFP180MCBQ850MBZV880MCAH760MCAL150MCAY870MCBF510MCBY350MCCB930MCCJ340MCCN900MCDD110MCDV830MCFA640MCFK060MCFT330MKAB610MKAH290MKAN410MHJY740MHLD270MHMW060MHMZ280MHNS800MHPT040MHRY250MHTY000MHVK930MHXA200MHXK730MJAX000MJCH780MCAJ250MBZQ410MBZV300MBZV890MCAM270MCAT660MCAT670MCAT680MCAW340MCBF210MCBG090MCBG440MCBN900MCBP540MCBZ560MCCA880MCCF140MCCL210MCCR210
- Amount recalled
- N/A
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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