BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test ent...

FDA Device Recall #Z-2628-2014 — Class II — July 28, 2014

Recall Summary

Recall Number Z-2628-2014
Classification Class II — Moderate risk
Date Initiated July 28, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Becton Dickinson & Co.
Location Sparks, MD
Product Type Devices
Quantity 28540

Product Description

BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.

Reason for Recall

These lots of Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms. Agar that allows susceptible enterococci to grow appears as a falsely resistant culture. If a lab does not QC, the error would be identified as falsely resistant enterococci would have further AST workup. There could be a delay in the identification of false-resistance

Distribution Pattern

Worldwide Distribution: US (Nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to the countries of Belgium, Canada, Colombia, India, Mexico, Singapore and Taiwan.

Lot / Code Information

Lot numbers - 4080291 4042217 4048040 4052349 4058242 4073274 4127728

Other Recalls from Becton Dickinson & Co.

Recall # Classification Product Date
Z-0484-2026 Class II BD Kiestra" Isolate Suspension Cuvette Array; ... Oct 23, 2025
Z-0235-2026 Class II BD EpiCenter Microbiology Data Management Syste... Sep 23, 2025
Z-0236-2026 Class II BD BACTEC Blood Culture System, labeled as the ... Sep 23, 2025
Z-0240-2026 Class II BD Veritor Connect Software, labeled as the fol... Sep 23, 2025
Z-0237-2026 Class II BD BACTEC Blood Culture System, labeled as the ... Sep 23, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.