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Terminated

BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

FDA Recall Z-2752-2017 · Posted None

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2016-09-16
Date Terminated2018-03-20
Product Quantity547,600 units

Reason for Recall

BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Firm Action

BD sent recall letter/return response form on 9/16/2016.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110771BD SINGLE USE, HYPODERMIC SYRINGEBecton, Dickinson and Company · 2011-05-13

Official Source

View FDA Recall →

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

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