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Recall Observatory FDA recall evidence

Device 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.

Z-2673-2014

July 22, 2014

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 69047
Status
Terminated
Classification
Class II
Quantity
3,088,320 units
Official record key
device-enforcement:Z-2673-2014

Official wording

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

Code information: REF #306553 Lot numbers 3024261 - exp 12-2015 3046276 - exp 01-2016 4128353 - exp 04-2017

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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