Fresenius Peritoneal Dialysis Premier Luer Lock Transfer… recallZ-0017-05 · Fresenius Medical Care North America · initiated Sep 20, 2004
Terminated All recalls posted in October 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care North America or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Peritoneal Dialysis Transfer Set may have occluded pathway
FDA root cause category: Other
What the company is doing
Fresenius Medical is conducting telephone contact to the dialysis clinics starting 9/20/04 and follow-up with a notice to be mailed o/a 9/27/04.Clinics are requested to examine inventory for lot numbers and return unused product to Fresenius.
Recall details
- Recall number
- Z-0017-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 20, 2004
- Posted by the FDA
- Oct 13, 2004
- Recalling firm
- Fresenius Medical Care North America
- Quantity
- 3,510 units
- Product code
- KDJ
- FDA submissions
- K822550
- Distribution
- Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON
Product description
Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
Code information (models, lots, serial numbers)
Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290
Other devices under the same FDA submission
1 device cleared under K822550 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- stay.safe® 050-95003Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall11 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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