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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89046

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

Open FDA event record

Event summary

Timeline bucket
October 28, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stradis Medical, LLC dba Stradis Healthcare

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

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Z-0400-2022
Recall number
Z-0400-2022
Initiated
October 28, 2021
Classification
Class II
Status
Terminated
Quantity
620 tube sets

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.

Code information

Lot code 20519-2103

Distribution pattern

NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH