Device Recall Fresenius Liberty Cycler 의 리콜

Recall

60865

Class 2

Z-1448-2012

2012-03-30

2012-04-24

Terminated

United States

2016-08-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106684

Increased risk of intraperitoneal volume (iipv), referred to as overfill.

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.