Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028
This recall has been terminated (originally issued May 3, 2006).
- Recall Initiated
- March 22, 2006
- Posted
- May 3, 2006
- Terminated
- July 11, 2006
- Recall Number
- Z-0834-06
- Quantity
- 141,770 units
- Firm Location
- Lexington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Stay safe trigger body may not connect to the extension set and result in associated peritonitis
Distribution
Nationwide Canada
Lot / Code Info
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
Root Cause
Other
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.
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