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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm March 04, 2005
Date Posted April 13, 2005
Recall Status1 Terminated 3 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 2
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.
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