Class 2 Device Recall Centeze Centesis Catheter

• Date Initiated by Firm: May 02, 2018
• Create Date: July 27, 2018
• Recall Status: Terminated on July 20, 2020
• Recall Number: Z-2563-2018
• Recall Event ID: 80021
• Product Classification: Cadiovascular, Introducer catheter - Product Code KGZ
• Product: Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
• Code Information: Lot #: a) 18043101; b) 18124426, 18120765
• Recalling Firm/ Manufacturer: Galt Medical Corporation; 2220 Merritt Dr; Garland TX 75041-6137
• For Additional Information Contact: David Derrick; 214-778-1306
• Manufacturer Reason for Recall: The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
• FDA Determined Cause: Other
• Action: On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees.
• Quantity in Commerce: 300
• Distribution: U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
• 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.