Recall Z-1222-04 ยท LZG Pump, Infusion, Insulin
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.
| Date | Jul 20, 2004 (initiated May 17, 2004) |
| Status | Terminated |
| Reason | Lack of assurance of sterility. |
| Root cause | Other |
| 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. |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973044 | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP Disetronic Medical Systems, Sep 15, 1997 |