BD PosiFlush Prefilled Saline Syringes Recalled for Incorrect Stopper
Becton Dickinson is recalling 5,085,120 BD PosiFlush Prefilled Saline Syringes due to an incorrect stopper that increases injection force and may trigger pump alarms.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with no reported illnesses or injuries. The recalled product presents a theoretical operational risk (increased injection force potentially triggering pump alarms) rather than direct patient safety threat.
Plain-English summary
BD (Becton Dickinson & Company) is recalling PosiFlush Prefilled Saline Syringes (10mL syringe with 10mL saline fill, Catalog Number 306547). An incorrect stopper was used in nine affected lot numbers: 3207548, 3207555, 3214826, 3226386, 3214828, 3226388, 3250302, 3250303, and 3250304.
The incorrect stopper causes an increase in injection force. When these syringes are used with a syringe pump, the increased force has the potential to trigger pump alarms.
Approximately 5,085,120 units were distributed nationwide throughout the United States.
Healthcare providers and consumers using these syringes should stop use of the affected lots and contact BD for instructions regarding return or replacement of the recalled product.
The recalled product
- Product
- PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 5,085,120
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)
- UDI-DI: 30382903065470
Distribution
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