Atlas FDA

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

FDA device recall Z-0049-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Medtronic Neurosurgery
Reason for recall
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Action taken
Firm sales representatives will contact customers and hand deliver the recall notice.
Root cause
Labeling mix-ups
Status
Terminated
Product code
GWG
Quantity affected
10
Distribution
TN, CO, GA and Japan
Date initiated
2003-09-15
Date posted
2004-07-20
Date terminated
2003-10-21
Location
Goleta, CA

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Related 510(k) clearances

RecordFirmDate
NEURO CHANNEL ENDOSCOPE MODEL 2232 (K945633)Clarus Medical Systems, Inc.1995-09-19