PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 26, 2017 Initiated: September 16, 2016 #Z-2751-2017

Product Description

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

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 of 10-6.

Details

Units Affected
648,000 units
Distribution
Nationwide Distribution
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Becton Dickinson & Company. Units affected: 648,000 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 26, 2017. Severity: Moderate. Recall number: Z-2751-2017.