Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and
FDA device recall Z-0017-05 · posted 2004-10-13 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care North America
- Reason for recall
- Peritoneal Dialysis Transfer Set may have occluded pathway
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDJ
- Quantity affected
- 3,510 units
- Distribution
- Nationwide Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON
- Date initiated
- 2004-09-20
- Date posted
- 2004-10-13
- Date terminated
- 2006-06-28
- 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 |
|---|---|---|
| SAFE LOCK TITANIUM ADAPTER SET (K822550) | American Medical Products, Inc. | 1982-10-13 |