Recall Z-0629-2012 ยท LDR Controller, Infusion, Intravascular, Electronic
ConMed Corporation
STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. For controlling the infusion of Intravenous fluids into the human body.
| Date | Jan 11, 2012 (initiated Apr 15, 2011) |
| Status | Terminated |
| Reason | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates. |
| Root cause | Mixed-up of materials/components |
| Action | ConMed Corporation sent Urgent Medical Device Recall Letters and Response Forms dated April 14, 2011, via UPS Priority Mail pouches to all domestic consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The international consignees were sent Urgent Medical Device Recall Letters and Response Forms dated April 22, 2011, via FedEx International Priority. Users were instructed to immediately stop use of the device and return it to ConMed Corporation. --- RECALL EXPANSION: Consignees were also instructed to contact all of those organization wi |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada, Panama and India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905498 | STAT 2 IV PUMPETTE The Master Medical Corp., Apr 16, 1991 |