Recall Z-0861-2016 ยท FPA Set, Administration, Intravascular
Centurion Medical Products Corporation
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.
| Date | Feb 23, 2016 (initiated Jan 19, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, RyMed Technologies, LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 1/4/2016 to the affected customers via certified mail on 1/19/2016 with instructions for identifying and returning the affected product. The recall letter included a description of the reason for the recall, affected product, actions to be taken, and instructions for responding to the formal recall notification. The customers were instructed to discontinue distribution and/or use and return product to: RyMed Technologies, LLC, 6000 W. William Cannon Drive, Building B, Suite 300, Austin, TX 78749; that use |
| Quantity | 1130 |
| Distribution | US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.