Recall Z-1705-2009 ยท FPA Set, Administration, Intravascular
Medtronic MiniMed
Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or MMT-332) and Paradigm external insulin infusion pumps to deliver insulin (subcutaneously) to patients who require exogenous insulin to maintain glycemic control.
| Date | Jul 16, 2009 (initiated Jun 29, 2009) |
| Status | Terminated |
| Reason | Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered. |
| Root cause | Process control |
| Action | Medtronic issued an "URGENT MEDICAL DEVICE RECALL" notification letter dated July 6, 2009 to health care professionals, followed by notification letters dated July 7, 2009 to distributors, inactive and active customers. Letters to healthcare professionals and distributors were sent via UPS 2-Day Air with signature confirmation of delivery required. On July 8, 2009 and July 9, 2009, a notification letter, along with replacements sets, were mailed via UPS to active patients or customers (who have ordered since January 2009). The notification letter to patients (inactive customers) who last |
| Quantity | 28,007,256 units |
| Distribution | Worldwide Distribution -- US, Canada, Mexico, Bermuda, Brazil, United Kingdom, Ecuador, Paraguay, Kuwait, Germany, El Salvador and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011071 | PARADIGM QUICK-SET INFUSION SET Maersk Medical A/S, Jun 7, 2001 |