Z-1482-2011

ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA...

Name: Z-1482-2011 ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA...
Creator: Roche Insulin Delivery Systems Inc.
Published: 2011-02-24
License: https://open.fda.gov/license/

Disetronic Medical Systems / initiated 2011-02-24 / Terminated / root cause: design

FDA source

Roche Insulin Delivery Systems Inc. began a recall of ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. An infusion set for the subcutaneous infusion of... on 2011-02-24. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1482-2011
Status: Terminated
Initiated: 2011-02-24
Posted: 2011-03-10
Terminated: 2011-07-27
Recalling firm: Disetronic Medical Systems
Product: ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzerland
Product code: FRN Pump, Infusion
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1,454,918 million worldwide
Distribution: Worldwide Distribution -- US and Canada.
Product codes and lots: Part Number: 05511038001. Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.

Product code FRN

K100704Class IIAccu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion DeviceDisetronic Medical Systems AG / cleared 2010-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)