Device Recall ACCUCHEK FlexLink Plus 의 리콜

Recall

58015

Class 1

Z-1484-2011

2011-02-24

2011-03-10

Terminated

United States

2011-07-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97980

There is the potential to kink or bend the cannula when inserting the accu-chek flexlink plus infusion set. this can lead to under delivery and elevation of blood glucose levels.

Roche Insulin Delivery Systems sent urgent Product Recall letters, dated 2/21/2011. The letter identified the affected product and described the issue regarding kinked or bent cannulas. The firm requests that customers discontinue use of the ACCU-CHEK FlexLink Plus infusion set and return the unused stock. Customers are to contact their health care provider to determine if changes to their pump therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. The attached Customer Reply Card should be completed and return via mail or fax per the instructions on the card. The letter also lists some additional information pertaining to signs and symptoms. Questions regarding this recall should be directed to ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, 7 days a week.