Affected "Lot 8" Quick-set Infusion Sets
Only "Lot 8" Quick-set infusion sets with the reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 are being recalled.
- A small percentage 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 reservoir 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.
No other Medtronic infusion sets are affected by this recall, so you may also use any other Paradigm infusion sets you have available and have been trained on (including Quick-sets other than "Lot 8", Silhouette®, Sure-T®, Sof-set®, or Polyfin® infusion sets).