Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1733-2015 — AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

U.S. FDA — Device Enforcement · United States · 2015-04-22 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1733-2015
Date of alert
2015-04-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diabetes Care, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05458544001
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.