ClearanceBrief
Recall Z-1463-06 ยท KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

Becton Dickinson & Company

BD Direct Draw Adapters, Catalog Number 364896.

DateSep 9, 2006 (initiated Jun 21, 2006)
StatusTerminated
ReasonFirm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
Root causeOther
ActionBD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.
Quantity234,450 units
DistributionWorld wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, New Zealand. For European distribution, the products are shipped to Temse located in Belgium who ha
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.