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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95396

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

Open FDA event record

Event summary

Timeline bucket
September 17, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Datascope Corp.

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

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

Z-0311-2025
Recall number
Z-0311-2025
Initiated
September 17, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Datascope Corp.
Quantity
160 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is discrepant labeling on the inner and outer packaging of the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is discrepant labeling on the inner and outer packaging of the device.

Code information

UDI-DI: 10607567107974; Lot Number: 3000344298

Distribution pattern

International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.