Class 3 Device Recall

• Date Initiated by Firm: March 04, 2005
• Date Posted: April 13, 2005
• Recall Status: Terminated on December 28, 2005
• Recall Number: Z-0708-05
• Recall Event ID: 31375
• Product Classification: System, Blood Culturing - Product Code MDB
• Product: Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case.
• Code Information: Lot #144444SA, Expiration Date: 01/2006.
• Recalling Firm/ Manufacturer: Trek Diagnostic Systems; 982 Keynote Cir Ste 6; Cleveland OH 44131-1873
• For Additional Information Contact: 216-351-8735
• Manufacturer Reason for Recall: Blood culture bottles with an error in the bar code on the labels, were shipped.
• FDA Determined Cause: Other
• Action: The firm contacted its customers and notified them of the recall via telephone and fax on 3/4/2005 and a recall letter dated 3/4/2005 was sent to each customer via U.S. Mail on 3/7/2005. The letter states that a ''Return Goods Authorization'' for the amount of product shipped to each facility has been issued and asks that the customers return any unused portion of this lot to the firm for replacement.
• Quantity in Commerce: 223 cases [11,150 bottles]
• Distribution: The blood culture bottles were distributed to the following states within the U.S.: MA, NY, TX, OH, MD, KY, OR, MO, NJ, PA, MI, FL, IN, NC, KS, GA, WI, & 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.