CLASS II Device recall · Reported 14 Aug 2013 · FDA Enforcement Report

BD Vacutainer Multiple Sample recalled by Becton Dickinson &

Becton Dickinson & is recalling BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417, distributed nationwide in the US. The recall was initiated on 1 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMarketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.

Quantity recalled37,906,400 units

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-1923-2013
FDA event ID: 65322
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 1 May 2013
FDA classified: 7 Aug 2013
Reported: 14 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Infusion Pumps

Timeline

1 May 2013	Recall initiated by company
7 Aug 2013	Classified by FDA	+98 days
14 Aug 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

BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 recalled?

Yes. Becton Dickinson & recalled BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 on 1 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1923-2013.

Why was it recalled?

BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

Which lots are affected?

Marketing Status: Class II, 510K # K991088 Device Listing Number: D030347 Catalog number 367290, 367300 (CE), 368491, and 303380.

Where was it sold?

Nationwide Distribution

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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