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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
