ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK PLUS SET 6/100 10PK. An infusio
FDA device recall Z-1485-2011 · posted 2011-03-10 · Terminated
Recall details
- Recalling firm
- Roche Insulin Delivery Systems Inc.
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 1,454,918 million worldwide
- Distribution
- Worldwide Distribution -- US and Canada.
- Date initiated
- 2011-02-24
- Date posted
- 2011-03-10
- Date terminated
- 2011-07-27
- Location
- Fishers, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE (K100704) | Disetronic Medical Systems AG | 2010-05-14 |