Paradigm Model 511 and 512 Insulin Infusion Pumps
- Company
- Medtronic Minimed
- Recall Initiated
- August 29, 2003
- Posted
- November 27, 2003
- Terminated
- September 2, 2005
- Recall Number
- Z-0168-04
- Quantity
- Approximately 61,000 patients
- Firm Location
- Northridge, CA
Reason for Recall
Water ingresses into the device when in prolonged contact with water causing device to malfunction.
Distribution
Nationwide and Canada
Lot / Code Info
Codes are irrelevant
Root Cause
Other
Action Taken
The firm sent notifications to all pump users of record, all distributors and all certified pump trainers indications that the pumps should not be immersed in water. Canadian users were contacted by Medtronic Canada.
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