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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83587

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

Open FDA event record

Event summary

Timeline bucket
August 01, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Rocket Medical Plc

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

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Z-0512-2020
Recall number
Z-0512-2020
Initiated
August 01, 2019
Classification
Class II
Status
Terminated
Recalling firm
Rocket Medical Plc
Quantity
1081

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.

Code information

All lots (UDI): 05055270913678

Distribution pattern

Nationwide