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Recall Observatory FDA recall evidence

Device product

BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

Z-2751-2017

September 16, 2016

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 77513
Status
Terminated
Classification
Class II
Quantity
648,000 units
Official record key
device-enforcement:Z-2751-2017

Official wording

Reason: BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.

Code information: 6061746 2021-02 6082982 2021-02 6089821 2021-03 6117858 2021-04 6117863 2021-04 6117889 2021-04 6117891 2021-04 6146962 2021-04 6173697 2021-05 6173767 2021-06 6173779 2021-06 6208614 2021-07

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required of 10-6.