Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0050-04

Channel Neuroendoscope, Standard Resolution, 13 cm, Catalog No. 2232-003

Medtronic Neurosurgery / initiated 2003-09-15 / Terminated / root cause: labeling and UDI

Medtronic Neurosurgery began a recall of Channel Neuroendoscope, Standard Resolution, 13 cm, Catalog No. 2232-003 on . The reason FDA records is "Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0050-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic Neurosurgery
Product
Channel Neuroendoscope, Standard Resolution, 13 cm, Catalog No. 2232-003.
Product code
GWG Endoscope, Neurological
Reason for recall
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Root cause tag
labeling and UDI
FDA root cause
Labeling mix-ups
Action
Firm sales representatives will contact customers and hand deliver the recall notice.
Quantity in commerce
10
Distribution
TN, CO, GA and Japan
Product codes and lots
A22148