Medtronic MiniMed, Inc.: InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

Hazard

Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

Details from the source

Reason for recall: Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia. Distribution: US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH, VA, NY, TN, HI, MA, NJ, PA, CO, WI, GA, CT, NE, OR, LA, NM, SD, ND, IN, NV, WV, RI, AR, NH Quantity: 8,986 Lot/code info: REF/UDI-DI(GTIN)/Lot: MMT-105NNBLNA/763000827182/D0020, D0034, D0036, D0038, D0045, D0046, D0050, D0057; MMT-105NNGYNA/763000827199/D0026, D0037, D0039, D0041, D0042, D0043, D0049; MMT-105NNPKNA/763000827205/D0029, D0030, D0040, D0051, D0062; MMT-105ELBLNA/763000827151/D0021, D0033, D0035, D0044, D0059, D0060, D0061; MMT-105ELGYNA/763000827168/D0031, D0032, D0047, D0068; MMT105ELPKNA/763000827175/D0027, D0028, D0048

UPC codes

763000827182, 763000827199, 763000827205, 763000827151, 763000827168, 763000827175

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.