Recall Z-2751-2017— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2016-09-16, terminated 2018-03-20. It names one FDA 510(k) clearance: K110771. 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. 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..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-16
- Terminated
- 2018-03-20
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.