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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95649

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

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Event summary

Timeline bucket
November 06, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ICU Medical, 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

ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Z-0652-2025
Recall number
Z-0652-2025
Initiated
November 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
ICU Medical, Inc.
Quantity
6000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to finished goods incorrectly packaged and labeled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to finished goods incorrectly packaged and labeled.

Code information

Model/Catalog Number: CL-80 UDI code: (01)10887709057125(17)290401(30)50(10)13959938 Lot Number: 13959938

Distribution pattern

Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.