Z-1805-2013 Class II Terminated
FDA device recall Z-1805-2013 was initiated by Becton Dickinson & Co. on Jun 6, 2013 and is designated Class II. Reason for recall: Microbiological identification media may exhibit reduced levels of Vancomycin. The recall status is terminated (terminated Sep 3, 2013). Affected quantity: 293 cartons.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 31, 2013
- Initiation Date
- Jun 6, 2013
- Termination Date
- Sep 3, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 293 cartons
Product Description
BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.
Reason for Recall
Microbiological identification media may exhibit reduced levels of Vancomycin.
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
Code Information
Lot 3078430 Exp 5/30/13
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1805-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026