Recall Z-0830-06 ยท FFT Electrode, Ph, Stomach
Medtronic Gastroenterology / Urology
Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.
| Date | May 3, 2006 (initiated Jan 25, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 25 individual catheters |
| Distribution | within US only: MI, PA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.