Z-0834-06

Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal...

Name: Z-0834-06 Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal...
Creator: Fresenius Medical Care North America
Published: 2006-03-22
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2006-03-22 / Terminated

FDA source

Fresenius Medical Care North America began a recall of Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028 on 2006-03-22. The reason FDA records is "Stay safe trigger body may not connect to the extension set and result in associated peritonitis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0834-06
Status: Terminated
Initiated: 2006-03-22
Posted: 2006-05-03
Terminated: 2006-07-11
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Stay safe trigger body may not connect to the extension set and result in associated peritonitis
FDA root cause: Other
Action: Fresenius Medical notified customers by telephone on 3/24/06 for initial lots recalled and followed by letter dated 3/30/06 to include all lots numbers recalled.
Quantity in commerce: 141,770 units
Distribution: Nationwide Canada
Product codes and lots: Lot Numbers: 5SR119; 52R124; 5SR125; 5SR149; 5SR150; 5SR173; 6AR014; 6AR015; 6AR032; 6AR044; 6AR045; 6AR055; 6AR069; 6AR085; 06AR086; 6AR267; 6AR280;6AR298; 6BR013;6BR031; 6BR040; 6BR043; 6BR064; 6BR075; 6BR091; 6BR092; 6BR110; 6BR127; 6BR141; 6BR281

Product code FKX

K002892Class IIFrsenius Pd Iqcard CyclerFresenius Medical Care North America / cleared 2001-04-05

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)