Recall Z-0319-2007 ยท FPA Set, Administration, Intravascular
Rymed Technologies, Inc.
RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.
| Date | Dec 30, 2006 (initiated May 25, 2006) |
| Status | Terminated |
| Reason | Weld failures on IV connector (area of female luer and spike body) |
| Root cause | Other |
| Action | Consignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product. |
| Quantity | 34,849 units. |
| Distribution | Nationwide Recall |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991653 | INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM Rymed Technologies, Inc., Jun 24, 1999 |