BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks

FDA device recall Z-0739-2013 · posted 2013-01-25 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.

Action taken

Becton Dickinson sent an Urgent Product Recall letter dated December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to discontinue use and discard any remaining product for replacement. Customers were also advised that due to an anticipated extended delay for the availability of Fildes Enrichment, BD will substitute DIFCO" Supplement B with Reconstituting Fluid as the replacement product. Customers were advised to ensure that this replacement product is appropriately validated in accordance with their laboratory's procedures. Customers with questions should contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4000.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

JSC

Quantity affected

11,710 tubes

Distribution

Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.

Date initiated

2012-12-10

Date posted

2013-01-25

Date terminated

2013-07-01

Location

Sparks, MD