The Recall Desk
HighFDA (Devices)·Z-0861-2016·Announced 2016-03-02

Centurion Convenience Kits Recalled Due to Cracking IV Connector Threads

Centurion Medical Products is recalling convenience kits containing In-Vision-Plus Needleless IV Connectors because molding defects may cause threads to crack and tubing to detach.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential interruption of IV or blood administration due to tubing detachment, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Centurion Medical Products Corporation is recalling specific convenience kits that contain an In-Vision-Plus Needleless IV Connector (Model code RYM5001). The recall is being conducted by the manufacturer, RyMed Technologies, LLC. The affected kits are used for single-patient IV and blood administration.

The recall is due to a component molding abnormality that may cause the female luer threads on the connector to crack. This defect creates a potential for the mating tubing set to become detached, which could interrupt the administration of IV fluids or blood. Other components within these kits are not affected by the issue.

The recall involves 1,130 units distributed in the United States to the states of Texas, Florida, Virginia, Tennessee, Pennsylvania, Illinois, Georgia, and California. Specific batch numbers and expiration dates are listed in the official recall documentation. Healthcare facilities and consumers should check their inventory for the affected model code and batch numbers. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to their instructions.

The recalled product

Product
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
Affected units
1,130

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • ECVC1010 CVC INSERTION BUNDLE - 3L

Distribution

Distributed in 8 states: