The Recall Desk
ModerateFDA (Devices)·Z-0736-2024·Announced 2024-01-24

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.

What this means for you

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
Hazard
  • increased-injection-force
  • equipment-incompatibility

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

Distributed nationwide across the United States.