Date Initiated by Firm |
July 28, 2003 |
Date Posted |
September 23, 2003 |
Recall Status1 |
Terminated 3 on January 12, 2007 |
Recall Number |
Z-1244-03 |
Recall Event ID |
26847 |
510(K)Number |
K991376
|
Product Classification |
Pump, Infusion, Insulin - Product Code LZG
|
Product |
Disetronic Dahedi insulin infusion pump; catalog # 8500019. |
Code Information |
All units |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Road Indianapolis IN 46250-0457
|
For Additional Information Contact |
customer service 800-688-4578
|
Manufacturer Reason for Recall |
Lack of assurance of reliability.
|
FDA Determined Cause 2 |
Other |
Action |
A recall letter dated 8/5/03 was issued to each user instructing them that they will receive a new pump and, upon receipt of the new pump, they will be required to return their Dahedi pump to the firm's representative. |
Quantity in Commerce |
508 |
Distribution |
United States. |
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
|