| Date Initiated by Firm | March 22, 2006 |
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| Date Posted | May 03, 2006 |
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| Recall Status1 |
Terminated 3 on July 11, 2006 |
| Recall Number | Z-0834-06 |
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| Recall Event ID |
35184 |
| 510(K)Number | K002892 |
|---|
| Product Classification |
System, Peritoneal, Automatic Delivery - Product Code FKX
|
| Product | Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis.
Catalog Number: 050-87028 |
|---|
| Code Information |
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 |
Recalling Firm/
Manufacturer |
Fresenius Medical Care North America
95 Hayden Avenue
Lexington MA 02421-7942
|
| For Additional Information Contact | Arthur E. Eilinsfeld
781-402-9009 |
|---|
Manufacturer Reason
for Recall | Stay safe trigger body may not connect to the extension set and result in associated peritonitis |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Quantity in Commerce | 141,770 units |
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| Distribution | Nationwide
Canada |
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| 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 = FKX
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