Class 3 Device Recall

• Date Initiated by Firm: July 11, 2003
• Date Posted: August 06, 2003
• Recall Status: Terminated on January 28, 2004
• Recall Number: Z-1086-03
• Recall Event ID: 26700
• PMA Number: P850020 P850020S011
• Product Classification: Columns, Immunoadsorption In Extracorporeal Systems - Product Code LQQ
• Product: Prosorba Protein A Immunoadsorption Column
• Code Information: Lot #PNC001A
• FEI Number: 3002987955
• Recalling Firm/ Manufacturer: Fresenius Hemocare, Inc.; 6675 185th Ave. NE; Suite 100; Redmond WA 98052
• For Additional Information Contact: 425-497-1197
• Manufacturer Reason for Recall: No package insert
• FDA Determined Cause: Other
• Action: A letter dated July 10, 2003 was sent to each customer. Enclosed with the letter was the prescribing information, patient guide and column holder.
• Quantity in Commerce: 19 cases/6 columns each
• Distribution: The firm distributed to 10 hospitals and health care facilities in AZ, CA, MI, MN, MO, PA, TN, TX, VA.
• 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.