Bact/Alert Blood Collection Adapter Cap and Insert

• • Terminated Z-1336-2012 FDA Not yet classified ·initiated 5 Mar 2012

  The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick.

510(k) Number

K933939 ↗

FDA Product Code

GIM

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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