FDA Recall: Infusion Sets Used With Insulin Pumps
Quick-set infusion sets made by Medtronic Inc. that are used with MiniMed Paradigm insulin pumps have been recalled because the infusion sets may not allow the insulin pump to vent air pressure properly. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a person with diabetes.
Affected infusion sets have lot numbers starting with the number “8” and have one of these reference numbers:
- MMT-396
- MMT-397
- MMT-398
- MMT-399
The lot number (for example, 8XXXXXX) is clearly marked on both the product box label and on each individual infusion set package.
The risk: The infusion set may deliver too much or too little insulin and may lead to serious injury or death.
Recommendations
* Stop using “Lot 8” Quick-set infusion sets.
* Return any affected infusion sets to the company, which will replace them at no additional charge. For more information, see Medtronic’s Web page or call Medtronic at 800-345-8139.
via FDA’s MedWatch Safety Alerts: August 2009.
Short URL: http://www.openaccesshealthcare.com/?p=67
Posted by admin
on Aug 9 2009. Filed under Recall Alerts.
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