ClearanceBrief
Recall Z-1227-04 ยท LZG Pump, Infusion, Insulin

Roche Diagnostics Corp.

Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and Panomat V infusion pumps, box of 25; catalog number 300.0420.

DateJul 20, 2004 (initiated May 17, 2004)
StatusTerminated
ReasonLack of assurance of sterility.
Root causeOther
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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K915566DISETRONIC PANOMAT PUMP
Disetronic Medical Systems, Aug 7, 1992