| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01612-1 |
| Product Name/Description |
sleep.safe Set, sleep.safe Set Plus and sleep.safe Set Paed
(Tubing sets for Peritoneal Dialysis)
sleep.safe Set
Batch Numbers: XAS131, XCS241
sleep.safe Set Plus
Batch Numbers: XBS011, XBS252, XBS253, XCS221, XES09100, XES10100, XES12100, XES17100, XES31100
sleep.safe Set Paed
Batch Numbers: XAS221, XBS043
ARTG number: 123388 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
During the continuous monitoring of sleep safe tubing systems on the market, Fresenius Medical Care has become aware of an increased number of leakages caused by overwelded coils on the patient and the drainage line. Overwelded coils can lead to difficulties in unrolling the patient and drainage line and can result in rupturing the lines with pinholes, and thus leakages may occur. The possible damage might not be visually detected. The sleep safe cycler can also not detect such a leakage. Therefore, there is a potential risk of infection for the patient, particularly the development of peritonitis. The problem of overwelded lines has been analysed and solved in subsequent production. |
| Recall Action |
Recall |
| Recall Action Instructions |
Fresenius will be contacting patients (users) via hospitals and organising the exchange of potentially affected stock with replacements. In the interim, users are to follow the detailed handling instructions provided in the customer letter. Users are reminded to: - Unroll carefully the tube coils of the sleep safe sets. - If unrolling is not possible, discard the sets. - If unrolling is successful, check carefully the patient line for leakages during priming. For more information, please refer to https://www.tga.gov.au/alert/sleep-safe-tubing-systems-used-peritoneal-dialysis .
This action has been closed out on 14/06/2019
This action has been closed out on 14/06/2019 |
| Contact Information |
02 9466 8048 - Fresenius Medical Care |