From: jennno@... <jennno@...>
Subject: [InsulinPumpersSupport] Fwd: MedWatch - Medtronic Paradigm Quick-Set Infusion Sets:Nationwide recall because infusion sets may not allow insulin pump to vent air pressure properly, resulting in the device delivering too much or too little insulin
To: "Insulin Pumpers" <InsulinPumpersSupport@yahoogroups.com>
Date: Tuesday, July 14, 2009, 9:26 PM

Hi,
FYI for Medtronic users. 


----- Forwarded Message -----
From: "FDA MedWatch" <fda@service. govdelivery. com>
To: jennno@comcast. net
Sent: Monday, July 13, 2009 5:58:50 PM GMT -05:00 US/Canada Eastern
Subject: MedWatch - Medtronic Paradigm Quick-Set Infusion Sets:Nationwide recall because infusion sets may not allow insulin pump to vent air pressure properly, resulting in the device delivering too much or too little insulin

Medtronic Paradigm Quick-Set Infusion Sets

Audience: Diabetes healthcare professionals, patients

Medtronic, Inc. and FDA notified healthcare professionals and patients of a recall of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps because the affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8". Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Customers are being asked to return any affected infusion sets to the company.

Read the complete MedWatch Safety summary, including a link to the firm press release, at:

http://www.fda. gov/Safety/ MedWatch/ SafetyInformatio n/SafetyAlertsfo rHumanMedicalPro ducts/ucm171686. htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420