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Terminated

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.

FDA Recall Z-0708-05 · Posted 2005-04-13

Recalling FirmTrek Diagnostic Systems
Recall StatusTerminated
Product CodeMDB
Date Initiated2005-03-04
Date Terminated2005-12-28
Product Quantity223 cases [11,150 bottles]

Reason for Recall

Blood culture bottles with an error in the bar code on the labels, were shipped.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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