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