Class 2 Device Recall Cartridge Blood Set

• Date Initiated by Firm: May 02, 2008
• Date Posted: September 26, 2008
• Recall Status: Terminated on May 22, 2012
• Recall Number: Z-1860-2008
• Recall Event ID: 48148
• 510(K)Number: K070414
• Product Classification: Tubing set with and without anti-regurgitation valve - Product Code FJK
• Product: Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
• Code Information: Serial numbers: 04P158215 and below, 03P158XXX (all lots)
• Recalling Firm/ Manufacturer: Gambro Renal Products, Inc.; 14143 Denver West Pkwy; Lakewood CO 80401-3116
• For Additional Information Contact: 303-222-6566
• Manufacturer Reason for Recall: Dialysis tubing sets may have occlusions restricting blood flow.
• FDA Determined Cause: Process control
• Action: Customers were sent an "Urgent Product Safety Notice" letter on 05/02/2008. They were instructed to visually inspect all blood sets prior to connection to the dialyzer to ensure there were no occlusions or partial occlusions. On 05/27/2008, an "Urgent Product Recall" letter was sent to all customers requesting the return of all remaining affected blood sets.
• Distribution: Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and 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.

• 510(K) Database: 510(K)s with Product Code = FJK and Original Applicant = GAMBRO RENAL PRODUCTS