Recall Z-2555-2014 ยท OJR Vacuum Powered Body Fluid Collection Kit
Thermedx LLC
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
| Date | Aug 27, 2014 (initiated Feb 10, 2014) |
| Status | Terminated |
| Reason | A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded. |
| Root cause | Component design/selection |
| Action | Thermedx sent an Urgent Product Correction letter dated March 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were notified that the devices were in need of correction, and that it would be performed at their facilities by Thermedx. Customers with questions were instructed to call a Thermedx technical service representative at 1-888-542-9276. For questions regarding this recall call 440-542-0883. |
| Quantity | 21 |
| Distribution | Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL. |
| FDA record | Open on fda.gov |