Medical Device Recall: Z-0011-05

FDA Recalls dataset · Firm: Medtronic MiniMed · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-09-14 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0011-05.

Recall Res Number
Z-0011-05
Recalling Firm / Manufacturer
Medtronic MiniMed
FEI Number
3003166194
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-09-14
Date Posted
N/A
Date Terminated
2005-03-03
Product Code
LZG
Event Number
30059
Product Quantity
N/A
Product Description Medtronic MiniMed Paradigm Model 512
Reason for Recall Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
Action Details N/A
Distribution Pattern Nationwide & Spain
Code Information / Serial Numbers Paradigm model 512pumps with serial numbers that end in '-Axx4' . Where 'x' can be any number or letter.

Related Establishments / Registrations

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