The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while wa
FDA device recall Z-2555-2014 · posted 2014-08-27 · Terminated
Recall details
- Recalling firm
- Thermedx LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- OJR
- Quantity affected
- 21
- Distribution
- Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
- Date initiated
- 2014-02-10
- Date posted
- 2014-08-27
- Date terminated
- 2015-08-04
- Location
- Solon, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERMEDX FLUID MANAGMENT SYSTEM (K133799) | Thermedx, LLC | 2014-06-20 |
| THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 (K091939) | Thermedx, LLC | 2010-07-23 |