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.