Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog N
FDA device recall Z-0834-06 · posted 2006-05-03 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care North America
- Reason for recall
- Stay safe trigger body may not connect to the extension set and result in associated peritonitis
- Action taken
- 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
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 141,770 units
- Distribution
- Nationwide Canada
- Date initiated
- 2006-03-22
- Date posted
- 2006-05-03
- Date terminated
- 2006-07-11
- Location
- Lexington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRSENIUS PD IQCARD CYCLER (K002892) | Fresenius Medical Care North America | 2001-04-05 |