FDA-Device2016-03-02Class II
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.
Centurion Medical Products Corporation
Hazard
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.
Sold states
US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.
Affected count
1130
Manufactured in
100 Centurion Way, N/A, Williamston, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0861-2016Don't want to check this manually?
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