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Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

FDA Recall #Z-0693-2016 — Class II — December 15, 2015

Recall #Z-0693-2016 Date: December 15, 2015 Classification: Class II Status: Terminated

Product Description

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

Reason for Recall

The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).

Recalling Firm

Fresenius Medical Care Renal Therapies Group, LLC — Waltham, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

14,094 units

Distribution

Nationwide Distribution

Code Information

All lot numbers

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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