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; manufactured for Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 3001061.
FDA Recall Z-1225-04 · Posted 2004-07-20
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLZG
Date Initiated2004-05-17
Date Terminated2006-05-10
Reason for Recall
Lack of assurance of sterility.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.