CLASS II Device recall · Reported 17 Jul 2013 · FDA Enforcement Report
Fresenius Liberty Cycler Set Single Conn./Ext DL Product recalled
Fresenius Medical Care Holdings is recalling Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated, distributed nationwide in the US. The recall was initiated on 3 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1674-2013
- FDA event ID
- 65332
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2013
- FDA classified
- 10 Jul 2013
- Reported
- 17 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Jun 2013 | Recall initiated by company | |
| 10 Jul 2013 | Classified by FDA | +37 days |
| 17 Jul 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cassette may leak during set up or during peritoneal dialysis treatment
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated recalled?
Yes. Fresenius Medical Care Holdings recalled Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated on 3 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1674-2013.
Why was it recalled?
Cassette may leak during set up or during peritoneal dialysis treatment
Which lots are affected?
Lot 11PR08083
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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