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.
FDA Recall Z-0830-06 · Posted 2006-05-03
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Recalling FirmMedtronic Gastroenterology / Urology
Recall StatusTerminated
Product CodeFFT
Date Initiated2006-01-25
Date Terminated2006-12-21
Product Quantity25 individual catheters
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.
Firm 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.
Root Cause
Other
Distribution Pattern
within US only: MI, PA, TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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