Recall Z-0017-05 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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
| Date | Oct 13, 2004 (initiated Sep 20, 2004) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822550 | SAFE LOCK TITANIUM ADAPTER SET American Medical Products, Inc., Oct 13, 1982 |