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U.S. Department of Health and Human Services

Class 2 Device Recall Thermedx Fluid Management System

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  Class 2 Device Recall Thermedx Fluid Management System see related information
Date Initiated by Firm February 10, 2014
Date Posted August 27, 2014
Recall Status1 Terminated 3 on August 04, 2015
Recall Number Z-2555-2014
Recall Event ID 68986
510(K)Number K133799  K091939  
Product Classification Vacuum powered body fluid collection Kit - Product Code OJR
Product 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.
Code Information Model P4000 Serial numbers affected:  20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005  
Recalling Firm/
Manufacturer		 Thermedx LLC
31200 Solon Rd
Unit 1
Solon OH 44139-3556
For Additional Information Contact Niles Patel
440-542-0883
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 21
Distribution Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OJR and Original Applicant = THERMEDX LLC
510(K)s with Product Code = OJR and Original Applicant = THERMEDX, LLC
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