BD 5ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 22,400 units of 5ml syringes because several lots did not receive the specified dose of irradiation required to meet sterility standards.
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 risk-of-harm product (medical device) where the sterilization process was not fully met, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Becton Dickinson & Company is recalling 22,400 units of BD 5ml Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm), Catalog #305062. The affected products were distributed nationwide.
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 deviation from the sterilization process may affect the sterility of the medical devices.
Healthcare providers and facilities should check their inventory for the specific catalog number and code information (6204878 2021-07) to identify affected units. Users should stop using the recalled syringes and contact Becton Dickinson for instructions on return or replacement.
The recalled product
- Product
- BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 22,400
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)
- 6204878 2021-07
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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