| Date Initiated by Firm | May 29, 2019 |
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| Create Date | August 05, 2019 |
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| Recall Status1 |
Terminated 3 on November 19, 2020 |
| Recall Number | Z-2151-2019 |
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| Recall Event ID |
83164 |
| 510(K)Number | K173718 |
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| Product Classification |
System, peritoneal, automatic delivery - Product Code FKX
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| Product | 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 Number: 050-87212
(2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215
(3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216 |
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| Code Information |
All lots |
Recalling Firm/
Manufacturer |
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
|
Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Use error |
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| Action | Fresenius issued on 05/29/19 The IMPORTANT MEDICAL DEVICE INFORMATION notification explains to the Home Therapy Nurses/Clinics to review the new flyer with each of their APD patients who use a Liberty Cycler.
For the patient notification, it will encourage them to use and follow the attached instructional flyer during set up for their daily dialysis treatment. The notification will have a copy of the new step-by-step instructional flyer. Included is a Reply Form for confirmation the consignee read and understands the notice sent to them. |
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| Quantity in Commerce | 33732973 Cassettes; 18,674 Liberty Cyclers |
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| Distribution | US Nationwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = FKX
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