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U.S. Department of Health and Human Services

Class 1 Device Recall ACCUCHEK FlexLink Plus

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  Class 1 Device Recall ACCUCHEK FlexLink Plus see related information
Date Initiated by Firm February 24, 2011
Date Posted March 10, 2011
Recall Status1 Terminated 3 on July 27, 2011
Recall Number Z-1486-2011
Recall Event ID 58015
510(K)Number K100704  
Product Classification Infusion Pump - Product Code FRN
Product ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511003001. AC FLEXLINK PLUS SET 8/40 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

Code Information Part Number: 05511003001.  Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
Recalling Firm/
Manufacturer
Roche Insulin Delivery Systems Inc.
11800 Exit 5 Pkwy Ste 120
Fishers IN 46037-7989
For Additional Information Contact Todd Siesky
317-521-3966
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = DISETRONIC MEDICAL SYSTEMS AG
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