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Recall Observatory FDA recall evidence

Device 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.

Z-1923-2013

May 01, 2013

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 65322
Status
Terminated
Classification
Class II
Quantity
37,906,400 units
Official record key
device-enforcement:Z-1923-2013

Official wording

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

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

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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