Class 2 Device Recall Fresenius Liberty Cycler

• Date Initiated by Firm: March 30, 2012
• Date Posted: April 24, 2012
• Recall Status: Terminated on August 04, 2016
• Recall Number: Z-1448-2012
• Recall Event ID: 60865
• 510(K)Number: K043363
• Product Classification: System, peritoneal, automatic delivery - Product Code FKX
• Product: Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8.; ; The Fresenius Liberty Cycler is intended for acute or chronic peritoneal dialysis.
• Code Information: Product Codes: Cyclers: 180020, 180111 User Manuals: 480001 Handi-Guides: 480017 All machines operating on software versions earlier than version 2.8.
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: 800-662-1237
• Manufacturer Reason for Recall: Increased risk of intraperitoneal volume (IIPV), referred to as Overfill
• FDA Determined Cause: Software design
• Action: Fresenius Medical Care sent a Urgent Product Information letter dated March 30, 2012, and April 3, 2012, to all affected customers. The letter was sent via Certified Mail, Return Receipt Requested. The letter identified the product the problem and the action needed to be taken by the customer. Recall to occur in 2 phases: Phase I: Fresenius Medical Care notified all clinics with patients using Liberty Cyclers with software versions earlier than 2.8 that these patients are receiving updated User Manuals and Handi-Guides. These new materials will include updated descriptions of the safety warnings included with the materials provided with the release of software version 2.8. Clinics will also be informed that their patients will be receiving replacement cyclers with updated software within 12 months. These notifications via telephone and certified letter (return receipt requested). Following clinic notification, Fresenius Medical Care will contact patients operating Liberty Cyclers with software versions earlier than 2.8 by phone, informing them that they will be receiving updated User Manuals and Handi-Guides. In addition, these patients will be informed that they will be receiving replacement cyclers with updated software at some point in the future and that Fresenius Medical Care anticipates that the full timeline of cycler replacements will occur over several months. A certified letter return receipt requested will be sent to all patients after the initial phone contact containing the updated User Manuals and Handi-Guides. Phase II: Liberty Cyclers with updated software will be issued to customers using Liberty Cyclers with software versions earlier than 2.8 as inventory is available. Please complete and return the enclosed Reply Form, indicating receipt and understanding of this communication Further questions please call (1-800) 227-2572.
• Quantity in Commerce: 10,146 units
• Distribution: Worldwide Distribution -- USA (nationwide)
• 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 = FKX and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA