| |
Class 2 Device Recall |
 |
| Date Initiated by Firm |
May 17, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on May 10, 2006 |
| Recall Number |
Z-1224-04 |
| Recall Event ID |
28917 |
| 510(K)Number |
K973044
|
| 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, 1 cartridge; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 150.0042. |
| Code Information |
All lots. |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
888-215-5790
|
Manufacturer Reason
for Recall |
Lack of assurance of sterility.
|
FDA Determined
Cause 2 |
Other |
| 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. |
| Distribution |
Worldwide. |
| 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 = LZG and Original Applicant = DISETRONIC MEDICAL SYSTEMS
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