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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93204

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

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Event summary

Timeline bucket
September 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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 CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Z-0315-2024
Recall number
Z-0315-2024
Initiated
September 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
ROi CPS LLC
Quantity
134 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.

Code information

a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

Distribution pattern

MO