Reported Aug 14, 2019 · Terminated
Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in…
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction
- with the Liberty cycler as follows(1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual
- Patient Connector) Part Number050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single
- Patient Connector) Part Number050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector
- and extended drain line Part Number050-87216
- Lot codes and dates
- All lots
- Amount recalled
- 33732973 Cassettes; 18,674 Liberty Cyclers
Where it was sold
- Nationwide
Why it was recalled
Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
This product could cause temporary or reversible health problems — stop using it.
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