| Date Recall Initiated: |
March 2, 2004 |
|---|---|
| Product: |
MiniMed Paradigm Quick-set Infusion Sets. Models MMT-359S6, MMT-359S9, MMT-359L6 MMT-359L9 |
| Use: |
Administration sets are used to administer fluids from a container to a patient. Specifically, this device is an insulin administration set. Insulin administration sets are thin, plastic tubing, which deliver insulin from the insulin infusion pump to the body. At the end of the tubing is a soft, flexible cannula, which is a small, tapered tube. With the help of an insertion device, the cannula is inserted under the skin. One insulin infusion set is intended to be used for 2 or 3 days and then disposed of. |
| Recalling Firm: |
Medtronic MiniMed 18000 Devonshire St. Northridge, California 91325-1219 |
| Reason for Recall: |
There have been complaints of bent cannulas, occlusions within the tubing, leaking at the insertion site, and accidental dislodging of the infusion set while removing the insertion device. Additionally, there have been reports of adhesive failure, which causes the device to detach from the skin. These problems have resulted in the interruption of insulin flow to the patients. |
Public Contact: |
Mark Faillace Sr. Director, Device Regulatory Affairs and QA 818-576-5616 |
| FDA District: |
Los Angeles |
| FDA Comment: |
Patients should discontinue use of the Paradigm Quick-set Plus infusion sets as soon as they can obtain replacement units. The firm will provide free replacements via overnight delivery. Patients should call the 24-hour Help Line (Option 1) at 800-646-4633 (800 MINIMED) or contact the firm at www.minimed.com/QSP to exchange any unused infusion sets. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. |
For additional information on this product recall, see the Medtronic MiniMed website at: http://www.minimed.com/QSP. This site contains additional important information concerning the recall of this product including the letter sent to customers using these insulin sets, a product exchange form and additional frequently asked questions (FAQs) about this recall. Lastly, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00847.html. Scroll down to "Recalls and Field Corrections: Devices – Class I". |
Updated May 24, 2004
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