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Recall Observatory FDA recall evidence

Device product

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

Z-0500-2020

October 14, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 84113
Status
Terminated
Classification
Class II
Quantity
967,680
Official record key
device-enforcement:Z-0500-2020

Official wording

Reason: Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.

Code information: Lot Number: 9175971 UDI: 50382903065757

Distribution pattern: Distribution US Nationwide and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.