Class 2 Device Recall Bayer

• Date Initiated by Firm: September 26, 2003
• Date Posted: October 24, 2003
• Recall Status: Terminated on February 04, 2004
• Recall Number: Z-0066-04
• Recall Event ID: 27414
• 510(K)Number: K020616
• Product Classification: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
• Product: Bayer Rapidpoint 405 Blood Gas Analyzer
• Code Information: Software Versions below 3.1
• Recalling Firm/ Manufacturer: Bayer Corp.; 63 North Street; Medfield MA 02052-1688
• For Additional Information Contact: Thomas Flynn; 508-359-3877
• Manufacturer Reason for Recall: Potential for bias shift in pO2 values due to air bubble in sample path
• FDA Determined Cause: Other
• Action: Bayer notified each customer by telephone and followed with a FedEx letter dated 9/26/03 providing upgraded software version 3.1 to install .
• Quantity in Commerce: 494 units
• Distribution: Nationwide Foreign: Australia, Austria, Belgium. Canada, France, Germany, Italy, Japan, Korea, Mexico, Netherlands, Russia, S Ireland, Spain, Switzerland
• 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.

• 510(K) Database: 510(K)s with Product Code = CHL and Original Applicant = BAYER DIAGNOSTICS CORP.