—#86467

Product

BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part *** Becton Dickinson and Company, 7 Loveton Circle, Sparks, Maryland 21152 USA*** 800-638-8663 A general purpose liquid medium used for the cultivation of bacteria employed in the preparation of inocula for microdilution minimal inhibitory concentration (MIC) and identification (ID) tests.

FDA product code: KZI — Culture Media, Enriched
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot 8160911, exp June 04, 2009.

Why it was recalled

In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

The recalling firm notified direct accounts by an Urgent Product Recall letter on 02/19/09. The notification identified the affected product and stated the problem. The letter also advised that users discontinue use of the product and to discard any remaining packages. The attached response form should be completed and returned for replacement of product. If further assistance is needed regarding replacements, customers can contact BD Customer Service Department at 1-800-675-0908.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- Including states of CA, CO, FL, GA, IL, MI, MN, MT, NY, OH, PA, TN, TX, UT, and VA.

Timeline

Recall initiated: 2009-02-19
Posted by FDA: 2010-01-15
Terminated: 2010-02-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86467. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.