Exact FDA event identifier

Event 93653

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

Open FDA event record

Event summary

Timeline bucket: December 18, 2023
Product types: Device
Classifications: Class I
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 Operative LAP, Item Number 800943001; surgical convenience kit

Z-0620-2024

Recall number: Z-0620-2024
Initiated: December 18, 2023
Classification: Class I
Status: Terminated
Recalling firm: ROi CPS LLC
Quantity: 345 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

Code information

UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845

Distribution pattern

US distribution to Louisiana