BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowen

FDA device recall Z-1322-2012 · posted 2012-03-27 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Media fails to perform as intended with quality control organism Mycobacterium kansasii.

Action taken

The firm, BD Diagnostic Systems, sent an "URGENT PRODUCT RECALL" letter dated January 2012 to Ex-US BD sites via email and its customers via UPS ground shipment on 1/30/12. The letter identified the product, the problem and the action to be taken. The customers were instructed to discontinue use of the recalled lot numbers and discard any remaining packages. Customers were also instructed to complete and return the attached form whether or not they had any inventory remaining via fax to: BD Regulatory Compliance at 410-316-4285. The letter also informed the customers that BD has decided to discontinue this product. If further assistance is needed regarding credit, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MDB

Quantity affected

3900 tubes

Distribution

Worldwide Distribution - USA (nationwide) including states of: AL, CA, CT, IA, IL, KY, LA, MD, MI, MN, NC, NJ, NY, OH, PA, TN, VA, WA, and WV; and countries of : Belgium and Singapore.

Date initiated

2012-01-30

Date posted

2012-03-27

Date terminated

2012-04-02

Location

Sparks, MD