FDA Device recall Z-2942-2018
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT by Medical Components, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2942-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-12 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medical Components |
| Distribution | US |
Product
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)
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.
Identifiers
| code_info | MBZV810 MCFG890 MCAC560 MCBD000 MCBW980 MCCL620 MCCP130 MCDV260 MCDZ790 MCFP180 MCBQ850 MBZV880 MCAH76…MBZV810 MCFG890 MCAC560 MCBD000 MCBW980 MCCL620 MCCP130 MCDV260 MCDZ790 MCFP180 MCBQ850 MBZV880 MCAH760 MCAL150 MCAY870 MCBF510 MCBY350 MCCB930 MCCJ340 MCCN900 MCDD110 MCDV830 MCFA640 MCFK060 MCFT330 MKAB610 MKAH290 MKAN410 MHJY740 MHLD270 MHMW060 MHMZ280 MHNS800 MHPT040 MHRY250 MHTY000 MHVK930 MHXA200 MHXK730 MJAX000 MJCH780 MCAJ250 MBZQ410 MBZV300 MBZV890 MCAM270 MCAT660 MCAT670 MCAT680 MCAW340 MCBF210 MCBG090 MCBG440 MCBN900 MCBP540 MCBZ560 MCCA880 MCCF140 MCCL210 MCCR210 MCDD770 MCDT410 MCDY970 MCFB780 MKAD710 MKAJ860 MKAM300 MKAT740 MKBA780 MBYZ570 MCAT370 MCBF000 MCDP270 MKAH580 MKAN420 MHNZ640 MHRN880 MHWY580 MJJL550 MLAX320 MLCT010 MCBF810 MCFL300 MHKF210 MHLP880 MHMT220 MHNL490 MHRD110 MHSR490 MHXA140 MHYR000 MJBK230 MBZX830 MCAX290 MCAY730 MCBF100 MCBG080 MCBQ930 MCBZ390 MCCQ320 MCDB560 MCDL600 MCDW870 MCFA580 MCFT970 MCFY800 MKAA090 MKAB620 MKAG540 MKAT120 MHJM830 MHJV270 MHSF270 MHVB060 MHXH670 MHZR140 MCAY88 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2942-2018%22
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