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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85432

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 16, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton Dickinson & Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2065-2020
Recall number
Z-2065-2020
Initiated
April 16, 2020
Classification
Class II
Status
Terminated
Quantity
16,099,310 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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