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U.S. Department of Health and Human Services

Medical Devices

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Roche Insulin Delivery Systems, ACCU-CHEK FlexLink Plus Infusion Sets

Recall Class: Class I

Date Recall Initiated: February 24, 2011

Product: ACCU-CHEK FlexLink Plus Infusion Set

Part Numbers Lot Numbers
05511046001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05511054001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05511038001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05510970001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05510988001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05510961001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05511003001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05511020001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05510996001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05510945001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05510953001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05510937001GWX 001 up to GWX 206 and GWY 001 up to GWY 033
05511089001GWX 001 up to GWX 206 and GWY 001 up to GWY 033

This recall ONLY applies to the ACCU-CHEK FlexLink Plus infusion sets that were launched in November 2010.

ACCU-CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are NOT affected by this recall and can be continued as directed by a physician or other qualified health care provider.

See Firm Press Release and Firm Recall Letter under Additional Information below.

This product was manufactured and distributed from November 1, 2010 through February 20, 2011.

Use: This product delivers insulin from a pump to the body.

Recalling Firm:

Roche Insulin Delivery Systems, Inc.
11800 Exit 5 Parkway, Suite 120
Fishers, Indiana 46037-7989

Reason for Recall:

There is a potential for under-delivery of insulin due to a tube (cannula) which may become kinked or bent when inserting the ACCU-CHEK FlexLink Plus infusion set. If this remains unnoticed, this can result in under-delivery or no delivery of insulin. This can lead to elevated blood glucose levels (hyperglycemia). Hyperglycemia can lead to many serious health complications including death.

Public Contact:

For questions regarding this recall, contact ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, seven days a week.

FDA District: Detroit

FDA Comments:

On February 21, 2011, the company sent its customers an Urgent Product Recall Letter. The letter identified the affected product and described the issue regarding kinked or bent cannulas. The company requested its customers to STOP using the ACCU-CHEK FlexLink Plus infusion sets and return the unused products.

Patients are to contact their health care providers or caregivers to determine if changes to their therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set.

The Customer Reply Card should be completed and returned by mail or FAX according to the instructions on the card.

The letter also lists additional information pertaining to signs and symptoms of hyperglycemia. (See Firm Recall Letter under Additional Links below).

Questions about this recall should be directed to ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, seven days a week to receive support on obtaining alternative infusion sets. Until this issue is fixed, the ACCU-CHEK FlexLink Plus infusion sets will NOT be available.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links: