FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms.
- Recall number
- Z-1282-2012
- Recalling firm
- Becton Dickinson & Co.
- Product
- Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms.
- Status
- Terminated
- Initiated
- 2012-02-20
- Posted
- 2012-03-23
- Terminated
- 2012-06-18
- Reason
- In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
- Root cause
- Nonconforming Material/Component
- Action
- Becton Dickinson (BD) sent an "URGENT PRODUCT RECALL" letter dated February 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining affected product. BD will issue replacements for the discarded product. Additionally, an Acknowledgment Form was attached for customers to complete and return to the firm via fax to 410-316-4258. Contact BD Technical Services Department for questions regarding this notice.
- Quantity
- 6930 tubes
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan.
- Lot, serial or model codes
- Lot 1186346, exp June 22, 2012 Lot 1229762, exp August 03, 2012
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSC
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28