#309604 -- 10 mL syringe
FDA Recall Z-1058-05 · Posted 2005-07-28
Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2005-05-25
Date Terminated2005-12-02
Product Quantity409200 units
Reason for Recall
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
Firm Action
BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.
Root Cause
Other
Distribution Pattern
BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.