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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89710

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

Open FDA event record

Event summary

Timeline bucket
February 24, 2022
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
ROi CPS LLC

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

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

Z-0837-2022
Recall number
Z-0837-2022
Initiated
February 24, 2022
Classification
Class III
Status
Terminated
Recalling firm
ROi CPS LLC
Quantity
1750 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Recalled devices were packaged in convenience kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Recalled devices were packaged in convenience kits.

Code information

IV START LABOR BIRTH convenience kits: 1) Item No. 830110, Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002, Lots 91226, 90641, and 90446 (exp. MAY/12/2022)

Distribution pattern

US Nationwide distribution in the state of Missouri.