BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 648,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet the Sterility Assurance Level.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the failure to meet Sterility Assurance Level requirements for a medical device intended for injection poses a significant risk of infection, meeting the criteria for a Severe rating.
Plain-English summary
Becton Dickinson & Company is recalling 648,000 units of BD 3ml Syringes with Luer-Lok Tips, Catalog 309657. 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 of 10-6. The affected lots are distributed nationwide and include specific lot codes and expiration dates ranging from February 2021 to July 2021.
Health care professionals and facilities should stop using the affected syringes and contact Becton Dickinson for further instructions on the return or disposal of the product.
The recalled product
- 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
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 648,000
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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