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Terminated

BD 30ml Syringe Luer-Lok tip Sterile BD, Franklin Lakes, NJ Made in USA

FDA Recall Z-0719-2007 · Posted 2007-04-05

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2007-02-15
Date Terminated2007-07-19
Product Quantity332,400 units

Reason for Recall

The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.

Firm Action

Distributors were sent recall notification letters on February 1, 2007 Recall notification letters were sent to all direct accounts and potential end users via UPS second day air on February 15, 2007.

Root Cause

Other

Distribution Pattern

Nationwide.

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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