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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 17, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on May 10, 2006
Recall NumberZ-1225-04
Recall Event ID 28917
510(K)NumberK973044 
Product Classification Pump, Infusion, Insulin - Product Code LZG
ProductDisetronic 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; manufactured for Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 3001061.
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
ActionThe 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.
DistributionWorldwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LZG
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