Medtronic Diabetes is recalling its Quick-set infusion sets that have lot numbers starting with the number 8 and reference numbers MMT-396 through MMT-399.
The “Lot 8” Quick-set infusion sets, used with MiniMed Paradigm insulin pumps, are being recalled because they were manufactured with an added lubricant that was clogging the vents in approximately 2% of the sets from that lot, preventing the insulin pump from venting properly. This could potentially result in too much or too little insulin being delivered and may lead to serious injury or death.
Customers should stop using Lot 8 Quick-set infusion sets right away. Medtronic is providing replacement infusion sets to customers at no additional charge.
Limited quantities of Lot 8 infusion sets have been distributed in the Bahamas, Bermuda, Brazil, Canada, Ecuador, El Salvador, Germany, Kuwait, Mexico, Paraguay, Turkey, and the United Kingdom. In Canada, customers who have received the sets from Medtronic Diabetes will be contacted. Canadian customers who have questions or concerns should call Canada's customer service line at 1-800-284-4416 for more information.
No other Medtronic infusion sets are affected by this recall. Customers may use any other Paradigm infusion sets they have available and have been trained on (including Quick-sets other than Lot 8, and Silhouette, Sure-T, Sof-set, or Polyfin infusion sets), the company said online.