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U.S. Department of Health and Human Services

Class 2 Device Recall Zinetics Reference pH Catheter

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  Class 2 Device Recall Zinetics Reference pH Catheter see related information
Date Initiated by Firm January 25, 2006
Date Posted May 03, 2006
Recall Status1 Terminated 3 on December 21, 2006
Recall Number Z-0830-06
Recall Event ID 34535
Product Classification Electrode, Ph, Stomach - Product Code FFT
Product 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.
Code Information Lot 0001491
Recalling Firm/
Manufacturer		 Medtronic Gastroenterology / Urology
4000 Lexington Ave N
Shoreview MN 55126-2917
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 25 individual catheters
Distribution within US only: MI, PA, TX
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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