FDAClass IIJuly 26, 2017

BD 3ml Syringe Luer-Lok" Tip recall: Sterility Concern

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…

Why was BD 3ml Syringe Luer-Lok" Tip recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Becton Dickinson & Company
Quantity
648,000 units
Distribution
Nationwide Distribution
Recall date
July 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls