CLASS II Device recall · Reported 31 Jul 2013 · FDA Enforcement Report

BD BBL BCYE Selective Agar with PAV recalled by Becton Dickinson &

Becton Dickinson & is recalling BD BBL BCYE Selective Agar with PAV, distributed nationwide in the US. The recall was initiated on 6 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 3078348 Exp 6/27/13

Quantity recalled163 cartons

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-1804-2013
FDA event ID: 65614
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2013
FDA classified: 24 Jul 2013
Reported: 31 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

6 Jun 2013	Recall initiated by company
24 Jul 2013	Classified by FDA	+48 days
31 Jul 2013	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

Microbiological identification media may exhibit reduced levels of Vancomycin.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 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.

Where it was distributed

Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

Nationwide

Questions about this recall

Is BD BBL BCYE Selective Agar with PAV recalled?

Yes. Becton Dickinson & recalled BD BBL BCYE Selective Agar with PAV on 6 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1804-2013.

Why was it recalled?

Microbiological identification media may exhibit reduced levels of Vancomycin.

Which lots are affected?

Lot 3078348 Exp 6/27/13

Where was it sold?

Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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