Recall Z-1734-2015— Roche Diabetes Care, Inc.

Name: FDA recall Z-1734-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-22

Class II · Terminated

Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2015-04-22, terminated 2016-11-03. It names one FDA 510(k) clearance: K042887. Product: AccuChek Spirit insulin infusion pump.. Reason: 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.

Recalling firm: Roche Diabetes Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Terminated: 2016-11-03
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K042887 — ACCU-CHEK SPIRITDisetronic Medical Systems AG·cleared 2005-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AccuChek Spirit insulin infusion pump.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.