Becton Dickinson Recalls BD PosiFlush SF Saline Flush Syringes Due to Open Seals
Becton Dickinson is recalling 3,088,320 units of BD PosiFlush SF Saline Flush Syringes because some units were found with open seals.
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: The recall is classified as FDA Class II, and the hazard involves open seals which is a packaging/integrity issue without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Becton Dickinson & Company is recalling 3,088,320 units of BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL (REF 306553). The recall was initiated after the company received reports of open seals on the syringes.
The affected product is intended to be used only for the flushing of indwelling vascular access devices and is generally compatible for use with syringe pumps. The recall covers specific lot numbers: 3024261 (exp 12-2015), 3046276 (exp 01-2016), and 4128353 (exp 04-2017). The product was distributed nationwide.
Healthcare facilities and consumers should check their inventory for the specific reference number and lot numbers listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 3,088,320
Distribution
Distributed nationwide across the United States.
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