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Terminated

Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028

FDA Recall Z-0834-06 · Posted 2006-05-03

Recalling FirmFresenius Medical Care North America
Recall StatusTerminated
Product CodeFKX
Date Initiated2006-03-22
Date Terminated2006-07-11
Product Quantity141,770 units

Reason for Recall

Stay safe trigger body may not connect to the extension set and result in associated peritonitis

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002892FRSENIUS PD IQCARD CYCLERFresenius Medical Care North America · 2001-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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