Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases co

FDA device recall Z-0708-05 · posted 2005-04-13 · Terminated

Recall details

Recalling firm

Trek Diagnostic Systems

Reason for recall

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

Action taken

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

Status

Terminated

Product code

MDB

Quantity affected

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.

Date initiated

2005-03-04

Date posted

2005-04-13

Date terminated

2005-12-28

Location

Cleveland, OH