The Recall Desk
HighFDA (Devices)·Z-1923-2013·Announced 2013-08-14

BD Vacutainer Luer Adapter Recalled for Potential Blood Leakage and Low Draw Volume

Becton Dickinson is recalling BD Vacutainer Multiple Sample and Direct Draw Luer Adapters due to potential blood leakage and low draw volume.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (blood leakage and low draw volume) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.

Plain-English summary

Becton Dickinson & Company is recalling the BD Vacutainer Multiple Sample and Direct Draw Luer Adapter. This sterile, non-invasive medical device is used to connect venous access devices, such as needles and blood collection sets, to blood collection tubes.

The recall was initiated because the devices may experience blood leakage and low draw volume. The affected units were distributed nationwide. The specific catalog numbers involved are 367290, 367300 (CE), 368491, and 303380.

Healthcare providers and facilities should stop using the affected devices and contact Becton Dickinson for further instructions on handling the recall.

The recalled product

Product
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.
Affected units
37,906,400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.