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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69600

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

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Event summary

Timeline bucket
October 24, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aesculap, 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

The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

Z-0502-2015
Recall number
Z-0502-2015
Initiated
October 24, 2014
Classification
Class II
Status
Terminated
Recalling firm
Aesculap, Inc.
Quantity
1

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling on three units. The incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.

Code information

Item Number FV129 Lot Number 4506244166 Serial Number A10150

Distribution pattern

US Distribution in Kansas only.