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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90106

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

Open FDA event record

Event summary

Timeline bucket
April 28, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott

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

FIRMap" Catheter, 60mm Basket

Z-1213-2022
Recall number
Z-1213-2022
Initiated
April 28, 2022
Classification
Class II
Status
Terminated
Recalling firm
Abbott
Quantity
40 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incorrect product labeling

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

Incorrect product labeling.

Code information

Model Number: AR064060; UDI Number: ( 01) 0 0810591 02002 4 ( 17) 020531 ( 00) 1 2345678 95; Batch Numbers: 2158303 (Exp. Date: 30 NOV 2022), 2159876 (Exp. Date: 31 JAN 2023), 2156510 (Exp. Date: 30 SEP 2022), 2162996 (Exp. Date: 31 MAR 2023), 2159875 (Exp. Date: 30 NOV 2022), and 2159877 ( Exp. Date: 30 NOV 2022).

Distribution pattern

US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.