CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
Vancomycin Screen Agar recalled by Becton Dickinson &
Becton Dickinson is recalling Vancomycin Screen Agar, distributed nationwide in the US. The recall was initiated on 29 Jun 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0473-2016
- FDA event ID
- 71883
- Recalling firm
- Becton Dickinson, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2015
- FDA classified
- 23 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 29 Jun 2015 | Recall initiated by company | |
| 23 Dec 2015 | Classified by FDA | +177 days |
| 30 Dec 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Vancomycin Screen Agar
Where it was distributed
Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia, India, Mexico and Europe.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.
Which lots are affected?
catalog number 222204. Lot numbers 5041659, 5064921, 5076659, 5083712, 5097504, 5105955, 5130907, 5139626, and 5147941
Where was it sold?
Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia, India, Mexico and Europe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71883This product is part of a recall event; the main page for the event is Enterococcus Screen Agar QUAD Plate recalled by Becton Dickinson &.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Enterococcus Screen Agar QUAD Plate recalled by Becton Dickinson & | Becton Dickinson | Device Malfunction | Nationwide |
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