Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: ...
FDA Device Recall #Z-0861-2016 — Class II — January 19, 2016
Recall Summary
| Recall Number | Z-0861-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 19, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Centurion Medical Products Corporation |
| Location | Williamston, MI |
| Product Type | Devices |
| Quantity | 1130 |
Product Description
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code 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.
Reason for Recall
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.
Distribution Pattern
US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.
Lot / Code Information
ECVC1010 CVC INSERTION BUNDLE - 3L, 16CM Batch Exp. 2015042150 12/2016 2015061050 01/2017 2015062650 02/2017 2015071050 03/2017 2015081150 03/2017 ECVC1025 16CM CENTRAL LINE BUNDLE Batch Exp. 2015052750 12/2016 2015062250 01/2017 2015070150 02/2017 2015070950 03/2017 2015080650 03/2017 ECVC1425 20CM CENTRAL LINE BUNDLE Batch Exp. 2015041450 12/2016 2015052250 12/2016 2015062250 01/2017 2015070150 02/2017 ECVC1780 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 01/2017 ECVC3915 VANTEX TLC KIT: CURVED SUTURE NEEDLE Batch Exp. 2015040850 02/2017 2015042750 02/2017 2015070250 03/2017 2015081150 05/2017 ECVC3925 9F INTRODUCER: CURVED 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 KIT: CURVED SUTURE NDL Batch Exp. 2015060150 03/2017 2015061550 03/2017 2015080750 04/2017 ECVC4115 6FR INTRODUCER: CURVED SUTURE NEEDLE Batch Exp. 2015080550 01/2017 ECVC4170 AVA 3xi CVC BUNDLE Batch Exp. 2015070250 06/2016
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| Z-1091-2020 | Class II | Centurion- ENT SNUF3 SNUFFER KIT Y | Dec 11, 2019 |
| Z-1063-2020 | Class II | Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENA... | Dec 11, 2019 |
| Z-1090-2020 | Class II | Centurion- Skin Prep Kits SB1280 SKIN SCRUB KI... | Dec 11, 2019 |
| Z-1058-2020 | Class II | Centurion- Umbilical Trays UVT1045 UMBILICAL A... | Dec 11, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.