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Terminated

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

FDA Recall Z-0392-06 · Posted 2006-01-13

Recalling FirmMedtronic Gastroenterology / Urology
Recall StatusTerminated
Product CodeFFT
Date Initiated2005-12-09
Date Terminated2006-12-21
Product Quantity140 catheters

Reason for Recall

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.

Firm 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.

Root Cause

Other

Distribution Pattern

CA, CO, FL, MA, OH, PA. OUS to include Finland, Italy and Portugal

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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