Z-1997-2025 Class II Ongoing

Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.

Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.

Product Description / Item Number / UDI-DI code / Serial Number: Humalog/lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250013 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 SL240720021 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280004 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280005 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432 TR240950015 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 SL240720022 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340007 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340008 Humalog/lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250014 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280006 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340010 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250015 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 SL240720023 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250016 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280007 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250017 Basaglar Bigfoot Unity OMS Cap FG-300175 00850003506456 FR242280009 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250018 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250020 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340009 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280008 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250021 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 KL241710001 Fiasp Bigfoot Unity OMS Cap FG-300173 00850003506432 TR241570002 Bigfoot Unity Cap for Novolog ASM-10046* 00850003506173 FR242280014 Bigfoot Unity Cap for Toujeo ASM-10053* 00850003506197 ST240960003 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280010 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340011 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280011 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280012 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250022 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250023 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250026 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250024 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250025 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 SL240720024 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 FR242280013 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280018 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280015 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250029 Novolog/Aspart Bigfoot Unity OMS Cap FG-300174 00850003506449 FR242280016 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432 TR241570003 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250030 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250027 Humalog/Lispro/Lyumjev Bigfoot Unity OMS Cap FG-300171 00850003506418 KR242250028 Levmr FlxT/Tresiba-Degl Bigfoot Unity OMS Cap FG-300179 00850003506494 TL242340012 Lantus-Glargine Bigfoot Unity OMS Cap FG-300176 00850003506463 SL240720026 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432 TR241570004 Lantus-Glargine Bigfoot Unity DMS Cap FG-300176 00850003506463 SL240720027 Novolog/Aspart Bigfoot Unity DMS Cap FG-300174 00850003506449 FR242280017 Novolog/Aspart Bigfoot Unity DMS Cap FG-300174 00850003506449 FR242280019 Fiasp Bigfoot Unity DMS Cap FG-300173 00850003506432 TR241570005 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250031 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250032 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250033 Humalog/Lispro/Lyumjev Bigfoot Unity DMS Cap FG-300171 00850003506418 KR242250034 Lantus-Glargine Bigfoot Unity DMS Cap FG-300176 00850003506463 SL240720028