Centurion Medical Products product recalled over mold contamination

Recall date

January 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Centurion Medical Products Corporation recalls Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-P…

Recall number

Z-0861-2016

FDA classification

Class II

Brand / firm

Centurion Medical Products Corporation

Sold / distributed

US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.