Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1413-06

Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001

Disetronic Medical Systems / initiated 2006-07-13 / Terminated / root cause: design

Disetronic Medical Systems, Inc. began a recall of Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001 on . The reason FDA records is "The battery may turn the pump off without warning due to a design change in the battery". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1413-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Disetronic Medical Systems
Product
Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
Product code
LZG Pump, Infusion, Insulin
Reason for recall
The battery may turn the pump off without warning due to a design change in the battery.
Root cause tag
design
FDA root cause
Other
Action
Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice.
Quantity in commerce
6,604 packs to U.S. and Canada.
Distribution
Nationwide and Canada.
Product codes and lots
Lots 06010107, 06030242, 06040085, 06050110 and 06060126.