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 10 x 10 box (10 cartidges per blister pack; 10 blister packs per box; Manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 150.0157.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- May 17, 2004
- Posted
- July 20, 2004
- Terminated
- May 10, 2006
- Recall Number
- Z-1222-04
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of sterility.
Distribution
Worldwide.
Lot / Code Info
All lots.
Root Cause
Other
Action Taken
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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