—#106684

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.

FDA product code: FKX — System, Peritoneal, Automatic Delivery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K043363
Affected lot / code info: Product Codes: Cyclers: 180020, 180111 User Manuals: 480001 Handi-Guides: 480017 All machines operating on software versions earlier than version 2.8.

Why it was recalled

Increased risk of intraperitoneal volume (IIPV), referred to as Overfill

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Worldwide Distribution -- USA (nationwide)

Timeline

Recall initiated: 2012-03-30
Posted by FDA: 2012-04-24
Terminated: 2016-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.