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Terminated

Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001

FDA Recall Z-0049-04 · Posted 2004-07-20

Recalling FirmMedtronic Neurosurgery
Recall StatusTerminated
Product CodeGWG
Date Initiated2003-09-15
Date Terminated2003-10-21
Product Quantity10

Reason for Recall

Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.

Firm Action

Firm sales representatives will contact customers and hand deliver the recall notice.

Root Cause

Labeling mix-ups

Distribution Pattern

TN, CO, GA and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945633NEURO CHANNEL ENDOSCOPE MODEL 2232Clarus Medical Systems, Inc. · 1995-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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