ClearanceBrief
Recall Z-1053-05 ยท FMF Syringe, Piston

Becton Dickinson & Company

BD Syringes - #309585 -- Piston Syringe, Syringe 3ML LL Syringe.

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.
Quantity691200 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

This recall record lists no 510(k) number.