FDA Medical Device Recalls (openFDA)
Roche Insulin Delivery Systems Inc.: ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK PLUS SET 8/100 10PK. 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
- Recall number
- Z-1488-2011
- Recalling firm
- Roche Insulin Delivery Systems Inc.
- Product
- ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK PLUS SET 8/100 10PK. 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
- Status
- Terminated
- Initiated
- 2011-02-24
- Posted
- 2011-03-10
- Terminated
- 2011-07-27
- Reason
- 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
- 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
- 1,454,918 million worldwide
- Distribution
- Worldwide Distribution -- US and Canada.
- Lot, serial or model codes
- Part Number: 05510996001. Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
- 510(k) numbers
- ["K100704"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1000116163
- Firm city
- Fishers
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28