FDA Medical Device Recalls (openFDA)
Fresenius Medical Care North America: Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028
- Recall number
- Z-0834-06
- Recalling firm
- Fresenius Medical Care North America
- Product
- Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028
- Status
- Terminated
- Initiated
- 2006-03-22
- Posted
- 2006-05-03
- Terminated
- 2006-07-11
- Reason
- Stay safe trigger body may not connect to the extension set and result in associated peritonitis
- 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
- 141,770 units
- Distribution
- Nationwide Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K002892"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 3001451489
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28