Class 3 Device Recall D711, Reference Membranes, REF 942058

• Date Initiated by Firm: June 17, 2005
• Date Posted: August 02, 2006
• Recall Status: Terminated on September 14, 2011
• Recall Number: Z-1319-06
• Recall Event ID: 35665
• 510(K)Number: K041874
• Product Classification: in vitro diagnostic - Product Code CHL
• Product: D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
• Code Information: Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.
• Recalling Firm/ Manufacturer: Radiometer America Inc; 810 Sharon Dr; Westlake OH 44145-1598
• For Additional Information Contact: Vince Sigmund; 800-736-0600
• Manufacturer Reason for Recall: The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
• FDA Determined Cause: Other
• Action: The recalling firm notified their distributor/customers of this recall, via telephone on 6/17/2005, at which time, the customers were asked to destroy any and all suspect reference membranes found on-site and at their subaccount customer locations.
• Quantity in Commerce: 13 boxes/4 membranes per box
• Distribution: Nationwide, including TX, OK, MI, CO, NY, and Canada.
• 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 = RADIOMETER MEDICAL APS