BD 10 mL Syringes Recalled Due to Improperly Seated Stopper
Becton Dickinson is recalling 564,000 units of 10 mL syringes because the stopper is not properly seated in the syringe.
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 3/5 (High).
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 is classified as FDA Class II, and the defect (improperly seated stopper) presents a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Company is recalling 564,000 units of BD 10 mL Syringes with Luer-Lok tips. The affected products include the BD Luer-Lok Tip with Blunt Plastic Cannula (Catalog #303348), the BD Luer-Lok Tip with Blunt Fill Needle 18G (Catalog #305064), and the BD Luer-Lok Tip with BD Precision Glide Needle 20G (Catalog #305064). These syringes are intended for use by healthcare professionals for general purpose fluid aspiration and injection.
The recall was initiated because the stopper of the 10 mL BD Luer-Lok syringe is not properly seated in the syringe. The affected lots are #4209518, #4205576, and #4209524. The products were distributed nationwide in the United States.
Healthcare professionals and consumers should stop using these syringes immediately. Users should contact Becton Dickinson & Company for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD…
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 564,000
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 (3)
- Catalog #303348
- Lot #4209518 Catalog #305064
- Lot #4205576 Catalog #309644 Lot #4209524
Distribution
Distributed nationwide across the United States.
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