| | Class 2 Device Recall |  |
| Date Initiated by Firm | May 17, 2004 |
|---|
| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on May 10, 2006 |
| Recall Number | Z-1223-04 |
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| Recall Event ID |
28917 |
| 510(K)Number | K973044 |
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| Product Classification |
Pump, Infusion, Insulin - Product Code LZG
|
| Product | Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 300.0419. |
|---|
| Code Information |
All lots. |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
888-215-5790 |
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Manufacturer Reason
for Recall | Lack of assurance of sterility. |
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FDA Determined
Cause 2 | Other |
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| Action | The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges. |
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| Distribution | Worldwide. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = LZG
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