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Recall Observatory FDA recall evidence

Device product

BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535

Z-2065-2020

April 16, 2020

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 85432
Status
Terminated
Classification
Class II
Quantity
16,099,310 units
Official record key
device-enforcement:Z-2065-2020

Official wording

Reason: This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

Code information: Lots 8353952 9011582 9017875 9024676 9045702 9060999 9079716 9127571 9143529 9156595 9163601

Distribution pattern: Nationwide domestic distribution. Foreign distribution to Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, Australia, Canada, Mexico, Malaysia, New Zealand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.