Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9
FDA device recall Z-0830-06 · posted 2006-05-03 · Terminated
Recall details
- Recalling firm
- Medtronic Gastroenterology / Urology
- Reason for recall
- Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patient safety is not compromised. Clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.
- Action taken
- An Urgent Recall letter was issued to all affected customers 1/25/2006. This letter described the issue and listed what actions customers were to take to return affected product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFT
- Quantity affected
- 25 individual catheters
- Distribution
- within US only: MI, PA, TX
- Date initiated
- 2006-01-25
- Date posted
- 2006-05-03
- Date terminated
- 2006-12-21
- Location
- Shoreview, MN
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