ClearanceBrief
Recall Z-1451-04 ยท LZG Pump, Infusion, Insulin

Dana Diabecare USA LLC

DANA Diabecare II insulin pumps

DateSep 14, 2004 (initiated May 26, 2004)
StatusTerminated
ReasonThere is a switch malfunction that that may cause the unit not to respond when command key is depressed.
Root causeOther
ActionAn email was sent to the sales representatives requesting the return of the pumps. The patients were contacted by telephone and letters requesting the return of the pumps.
DistributionAZ, WV, PA, FL, WI, MI, TN, MD
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.