ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insu
Check against the official notice below — it lists the full affected range.
The ACCU-CHEK Spirit Combo insulin infusion pump, sold as part of the Accu-Chek Combo System, is subject to a recall affecting approximately 8,116 units distributed nationwide. A faulty capacitor in the pump may cause the device to lose its time and date settings during a power interruption, such as when changing the battery. When this occurs, the time and date reset to default values, and although the pump will prompt users to confirm these settings, if a user fails to notice the reset and does not correct the settings, the basal rate time blocks could shift to incorrect times.
The recall involves four specific product versions: the Accu-Chek Combo Kit in both English and Spanish versions, the Accu-Chek Spirit Combo Replacement Pump, and the Accu-Chek Spirit Combo Demo Pump. The affected products were distributed across the United States. The source document does not specify a remedy or action that consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
Reason for recall: The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur. Distribution: US Nationwide Distribution in the states of CA, CT, IA, NV, OH, IN, WI, GA, MO, NY, VA, LA, ME, TX, NC, ND, SD, NJ, CO, AL, SC, IL, KY, FL, OR, MN, MD, MS, AR, WV, WA, TN, CT, ID, KS, MI, PA, UT, MA, RI, NM, OK, DE, AZ, NE, MT, NV, WY, AK, and NH. Quantity: 8116 Lot/code info: Model/Catalog/Part Number: Accu-Chek Combo Kit mg US/English version, 05458544001 Accu-Chek Combo Kit mg US/Spanish version, 055004686001 Accu-Chek Spirit Combo Replacement Pump US/EN, 05391512001 Accu-Chek Spirit Combo Demo Pump- US, 0539175000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.