Recall record at a glance
| Official record | Z-0439-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Report date | Nov 18, 2020 |
| Recall initiation date | Sep 12, 2020 |
| Quantity | 9,907 devices |
| Location | Waltham, MA, United States |
Official product description
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Why the product was recalled
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
Distribution information
Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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