ClearanceBrief
Recall Z-1055-05 ยท FMF Syringe, Piston

Becton Dickinson & Company

# 309604 -- Syringe 10 mL LL

DateJul 28, 2005 (initiated May 25, 2005)
StatusTerminated
ReasonThe firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
Root causeOther
ActionBD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.
Quantity2028000 units
DistributionBD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K980987BECTON DICKINSON SYRINGE
Bd Becton Dickinson Vacutainer Systems Preanalytic, Jun 11, 1998