Recall Z-0392-06 ยท FFT Electrode, Ph, Stomach
Medtronic Gastroenterology / Urology
Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Distributed by / Medtronic Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA
| Date | Jan 13, 2006 (initiated Dec 9, 2005) |
| Status | Terminated |
| Reason | Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the Digitrapper pH recorder. |
| Root cause | Other |
| Action | Letters will be sent to distributors, end-users and Medtronic Field Personnel. The end-user will be asked to return via fax a confirmation/customer receipt. Letters identify the affected catalog number and lot numbers. Customers are asked to return affected product and will receive replacement product. |
| Quantity | 140 catheters |
| Distribution | CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.