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Fresenius Liberty Cycler Software, User Manuals, and… recallZ-1448-2012 · Fresenius Medical Care Holdings, Inc. · initiated Mar 30, 2012

Terminated All recalls posted in April 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1448-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 30, 2012
Posted by the FDA
Apr 24, 2012
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
10,146 units
Product code
FKX
FDA submissions
K043363
Distribution
Worldwide Distribution -- USA (nationwide)

Product description

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 (models, lots, serial numbers)

Product Codes:  Cyclers: 180020, 180111 User Manuals: 480001 Handi-Guides: 480017 All machines operating on software versions earlier than version 2.8.

Other devices under the same FDA submission

3 devices cleared under K043363 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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