FDA Medical Device Recalls (openFDA)
Fresenius Medical Care North America: Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
- Recall number
- Z-0017-05
- Recalling firm
- Fresenius Medical Care North America
- Product
- Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
- Status
- Terminated
- Initiated
- 2004-09-20
- Posted
- 2004-10-13
- Terminated
- 2006-06-28
- Reason
- Peritoneal Dialysis Transfer Set may have occluded pathway
- Root cause
- Other
- Action
- Fresenius Medical is conducting telephone contact to the dialysis clinics starting 9/20/04 and follow-up with a notice to be mailed o/a 9/27/04.Clinics are requested to examine inventory for lot numbers and return unused product to Fresenius.
- Quantity
- 3,510 units
- Distribution
- Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON
- Lot, serial or model codes
- Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290
- 510(k) numbers
- ["K822550"]
- PMA numbers
- not on file
- Product code
- KDJ
- 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