Roche Diabetes Care, Inc.: AccuChek Spirit insulin infusion pump.

Is my product affected?

AccuChek Spirit insulin infusion pump.

• UPC 05458544001
• UPC 05504686001
• UPC 05391512001
• UPC 05391750001
• UPC 04759702001
• UPC 04540492001
• UPC 04759729001

Check against the official notice below — it lists the full affected range.

What happened

Roche Diabetes Care, Inc. has recalled 35,795 Accu-Chek Spirit Combo and Accu-Chek Spirit insulin infusion pumps distributed nationwide. The pumps may experience increased mechanical errors that display E6 and E10 error messages. If users do not respond appropriately to these error messages, insulin delivery will stop, and if the error goes unnoticed, it may result in severe hyperglycemia.

The recall affects seven model variants, including combination kits and replacement pumps in English and Spanish versions. The source does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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.

Source

Official record: FDA (Device enforcement) ↗

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

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All FDA (Device enforcement) recalls