Reported Mar 2, 2016 · Terminated
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001…
Centurion Medical Products Corporation
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: Centurion Medical Products Corporation · 100 Centurion Way · Williamston, MI · 48895-9086
Is this the product you have?
- Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector
- Modelcode RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use
- Lot codes and dates
- ECVC1010 CVC INSERTION BUNDLE - 3L, 16CM Batch Exp.CENTRAL LINE BUNDLE Batch Exp.
201504215012/2016201506105001/2017201506265002/2017201507105003/2017201508115003/2017ECVC102516CM
CENTRAL LINE BUNDLE Batch Exp.201505275012/2016201506225001/2017201507015002/2017201507095003/2017201508065003/2017ECVC142520CM
TRIPLE LUMEN BUNDLE Batch Exp. 2015041450 01/2017 2015081350 05/2017 ECVC1785 QUAD LUMEN BUNDLE Batch Exp. 2015052150 01/2017 2015061850 03/2017 ECVC3015 CVC TRIPLE LUMEN BUNDLE Batch Exp. 2015061050 01/2017 2015061850 01/2017 ECVC3260 CVC INSERT BUNDLE 16CM Batch Exp. 2015061150 09/2016 2015061550 09/2016 ECVC3540 TRIPLE LUMEN PI CVC BUNDLE Batch Exp. 2015041350 12/2016 ECVC3575 CVC TRIPLE LUMEN BUNDLE - 20CM Batch Exp. 2015041550 10/2016 2015061050 01/2017201504145012/2016201505225012/2016201506225001/2017201507015002/2017ECVC1780
- ECVC3915 VANTEX TLC KITCURVED SUTURE NEEDLE Batch Exp.
201504085002/2017201504275002/2017201507025003/2017201508115005/2017
- ECVC3925 9F INTRODUCERCURVED SUTURE NEEDLE Batch Exp. 2015071750 01/2017 ECVC405 CVC MULTI-LUMEN INSERTION BUNDLE Batch Exp. 2015041750 12/2016 2015061050 01/2017 ECVC4095 AVA HIGH FLOW BUNDLE Batch Exp. 2015060450 08/2016
- ECVC4110 MULTI-MED TLC KITCURVED SUTURE NDL Batch Exp. 2015060150 03/2017 2015061550 03/2017 2015080750 04/2017
- ECVC4115 6FR INTRODUCERCURVED SUTURE NEEDLE Batch Exp. 2015080550 01/2017 ECVC4170 AVA 3xi CVC BUNDLE Batch Exp. 2015070250 06/2016
- ECVC1010 CVC INSERTION BUNDLE - 3L, 16CM Batch Exp.
- Amount recalled
- 1130
Where it was sold
Why it was recalled
Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. A component molding abnormality may cause female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. Other components within these kits are not affected.
This product could cause temporary or reversible health problems — stop using it.
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