BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 57,600 units of BD 3ml Syringes with PrecisionGlide Needles because some lots did not receive the required dose of irradiation to ensure sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a sterility defect (failure to meet Sterility Assurance Level), which poses a risk of infection or harm to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling 57,600 units of BD 3ml Syringe Luer-Lok Tip with BD PrecisionGlide Needle 23G x 1 (0.6mm x 25mm), Catalog #309571. The product is a single-use hypodermic syringe intended for use by health care professionals for general purpose fluid aspiration and injection.
The recall was initiated because BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required. This defect means the products may not be sterile as intended.
The affected units were distributed nationwide. Health care professionals and facilities should stop using the affected lots and contact Becton Dickinson for further instructions on return or disposal.
The recalled product
- Product
- BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 57,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 6117580 2021-03
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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