AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Check against the official notice below — it lists the full affected range.
Roche Diabetes Care, Inc. is recalling approximately 35,795 Accu-Chek Spirit Combo and Accu-Chek Spirit insulin infusion pumps distributed nationwide. The pumps may experience mechanical errors that cause E6 and E10 error messages to display. If users do not respond appropriately to these error messages, the pumps will stop delivering insulin, which could result in severe hyperglycemia if the problem goes unnoticed.
The recall affects multiple models and versions of the Accu-Chek Combo and Spirit pump systems sold in the United States and Canada, including replacement pumps, demo pumps, and kits available in English and Spanish. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u
Reason for recall: Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u Distribution: Nationwide Distribution Quantity: 35,795 Lot/code info: All Serial Numbers Models: 1. 05458544001, Accu-Chek Combo Kit mg US/English version. 2. 05504686001, Accu-Chek Combo Kit mg US/Spanish version. 3. 05391512001, Accu-Chek Spirit Combo Replacement Pump US/EN. 4. 05391750001, Accu-Chek Spirit Combo Demo Pump US. 5. 04759702001, Accu-Chek Spirit Pump Kit US/CA Back Up. 6. 04540492001, Accu-Chek Spirit Pump Kit US/CA. 7. 04759729001, Accu-Chek Spirit Replacement Pump.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.