Z-0017-05

Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector...

Name: Z-0017-05 Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector...
Creator: Fresenius Medical Care North America
Published: 2004-09-20
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2004-09-20 / Terminated

FDA source

Fresenius Medical Care North America began a recall of Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034 on 2004-09-20. The reason FDA records is "Peritoneal Dialysis Transfer Set may have occluded pathway". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0017-05
Status: Terminated
Initiated: 2004-09-20
Posted: 2004-10-13
Terminated: 2006-06-28
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
Product code: KDJ Set, Administration, For Peritoneal Dialysis, Disposable
Reason for recall: Peritoneal Dialysis Transfer Set may have occluded pathway
FDA root cause: Other
Action: 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.
Quantity in commerce: 3,510 units
Distribution: Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON
Product codes and lots: Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290

Product code KDJ

K822550Class IISafe Lock Titanium Adapter SetAmerican Medical Products, Inc. / cleared 1982-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)