Atlas FDA

# 309604 -- Syringe 10 mL LL

FDA device recall Z-1055-05 · posted 2005-07-28 · Terminated

Recall details

Recalling firm
Becton Dickinson & Company
Reason for recall
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
Action taken
BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.
Root cause
Other
Status
Terminated
Product code
FMF
Quantity affected
2028000 units
Distribution
BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
Date initiated
2005-05-25
Date posted
2005-07-28
Date terminated
2005-12-02
Location
Franklin Lakes, NJ

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Related 510(k) clearances

RecordFirmDate
BECTON DICKINSON SYRINGE (K980987)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-06-11