—#86955

Product

BD BACTEC(TM) Standard 10 Aerobic/F Medium, catalog 442260, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K921133
Affected lot / code info: 9238806 exp 6/30/2010 9267206 exp 7/31/2010 9267210 exp 7/31/2010 9267213 exp 7/31/2010

Why it was recalled

The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.

Root cause (FDA determination)

Component change control

Action the firm took

An "URGENT CUSTOMER NOTIFICATION" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when used as instructions indicate. The customers are being urged to pay close attention to their BACTEC blood collection procedure until they receive bottles with the revised labels. Drawing too much blood may contribute to false negative or false positive results. The customer is being ask to communicate this information to all specimen collection sites within their facility. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay

Timeline

Recall initiated: 2009-11-11
Posted by FDA: 2010-03-08
Terminated: 2010-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86955. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.