FDA-Device2014-10-01Class II

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.

Becton Dickinson & Company
Hazard

BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).

Sold states
Nationwide Distribution.
Affected count
3,088,320 units
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2673-2014

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