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Terminated

# 309604 -- Syringe 10 mL LL

FDA Recall Z-1055-05 · Posted 2005-07-28

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2005-05-25
Date Terminated2005-12-02
Product Quantity2028000 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.

K980987BECTON DICKINSON SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic · 1998-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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