PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 2, 2016 Initiated: January 19, 2016 #Z-0861-2016

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.

Details

Units Affected
1130
Distribution
US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.
Location
Williamston, MI

Frequently Asked Questions

What product 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.. Recalled by Centurion Medical Products Corporation. Units affected: 1130.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0861-2016.

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