Class 2 Device Recall HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT

• Date Initiated by Firm: May 05, 2009
• Date Posted: August 21, 2009
• Recall Status: Terminated on September 30, 2009
• Recall Number: Z-1732-2009
• Recall Event ID: 52018
• 510(K)Number: K960749
• Product Classification: Activated whole blood clotting time - Product Code JBP
• Product: Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems; International Technidyne Corp., Edison, NJ 08820. The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty.
• Code Information: Lot number K8JLR118.
• FEI Number: 1000526865
• Recalling Firm/ Manufacturer: International Technidyne Corp.; 6-8 Olsen Avenue; Edison NJ 08820-2419
• For Additional Information Contact: David E. Gronostajski; 732-548-5700
• Manufacturer Reason for Recall: One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
• FDA Determined Cause: Employee error
• Action: An "Urgent - Medical Device Recall" letter dated May 4, 2009 was sent to healthcare professionals. The recall letter described the reason for recall and the possible health risks involved. Consignees were asked to check their inventory for the affected lot number and return the completed Customer Account Tracking form via mail, e-mail or fax to ITC. ITC will make arrangements for the return of affected product. If there is no affected product in the inventory and no product or safety concerns, the letter is for information purposed only. Note: the Customer Account Tracking form should be completed in all cases. If you have questions regarding the recall information, please call ITC Technical Support at 1-800-579-2255, or email ITC at JACTLR@itcmed.com.
• Quantity in Commerce: 173 boxes of 45 cuvettes
• Distribution: Nationwide.
• 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 = JBP