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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90749

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

Open FDA event record

Event summary

Timeline bucket
August 12, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DeRoyal Industries Inc

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

DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors

Z-1668-2022
Recall number
Z-1668-2022
Initiated
August 12, 2022
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
1306 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Procedure packs contained a recalled product.

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

Procedure packs contained a recalled product.

Code information

NS CVR PREP PACK /89-6817.09; Lots 56391514 (exp 08/01/2023), 56926777 (exp 08/01/2023), 57103035 (exp. 08/01/2023); UDI-DI (GTIN): 00749756730938 NON-STERILE IR ADMISSION KIT / 89-8762.05; Lot 57104020 (exp 07/01/2023); UDI-DI (GTIN): 00749756883627

Distribution pattern

US Nationwide distribution in the states of OH and TN.