Roche Diagnostics Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 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.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Roche Diagnostics Corp. is recalling Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panom due to Lack of assurance of sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026