| Date Initiated by Firm | September 20, 2004 |
|---|
| Date Posted | October 13, 2004 |
|---|
| Recall Status1 |
Terminated 3 on June 28, 2006 |
| Recall Number | Z-0017-05 |
|---|
| Recall Event ID |
30007 |
| 510(K)Number | K822550 |
|---|
| Product Classification |
Set, Administration, For Peritoneal Dialysis, Disposable - Product Code KDJ
|
| 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 |
|---|
| Code Information |
Lot Numbers: 3LR240, 3NR190, 3SR074, 4AR119, 4BR187, 4CR290 |
Recalling Firm/
Manufacturer |
Fresenius Medical Care North America
95 Hayden Ave
Lexington MA 02421-7942
|
| For Additional Information Contact | Arthur Ellinsfeld
781-402-9068 |
|---|
Manufacturer Reason
for Recall | Peritoneal Dialysis Transfer Set may have occluded pathway |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 3,510 units |
|---|
| Distribution | Nationwide
Canada: Fresenius Medical Care Canada 258 East Pearce Street, Richmond Hill, ON |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = KDJ
|
|---|
