Devices

Device Recall AccuChek

Model / Serial
Lots 5A084UF, 5B138UF, 5C180UF, 5D233UF, 5E215UF, 5F268UF, 5G147UF, 5G158UF, 5H068UF, 5H122UF, 5H172UF, 5H204UF, 5H205UF, 5H207UF, 5I173UF, 5I236UF, 5K156UF, 5K184UF, 5L072UF, 5L104UF, 6A003UF and 6A111UF.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Product Description
Accu-Chek FlexLink Cannula 8; Ref number 04541219001. (Distributed outside of the U.S. only).
Manufacturer
Disetronic Medical Systems, Inc.
1 Event
- Recall of Device Recall AccuChek

Manufacturer

Disetronic Medical Systems, Inc.

Manufacturer Address
Disetronic Medical Systems, Inc., 11800 Exit 5 Parkway, Suite 120, Fishers IN 46038
Source
USFDA

73 devices with a similar name

Learn more about the data here

Device Recall ACCUCHEK FlexLink Plus

Model / Serial
Part Number: 05511046001. Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US and Canada.
Product Description
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK PLUS 6MM 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
Manufacturer
Roche Insulin Delivery Systems Inc.

Device Recall ACCUCHEK FlexLink Plus

Model / Serial
Part Number: 05511054001. Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US and Canada.
Product Description
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK PLUS 8MM 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
Manufacturer
Roche Insulin Delivery Systems Inc.

Device Recall ACCUCHEK FlexLink Plus

Model / Serial
Part Number: 05511038001. Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US and Canada.
Product Description
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
Manufacturer
Roche Insulin Delivery Systems Inc.

Device Recall ACCUCHEK FlexLink Plus

Model / Serial
Part Number: 05510970001. Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US and Canada.
Product Description
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 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
Manufacturer
Roche Insulin Delivery Systems Inc.

Device Recall ACCUCHEK FlexLink Plus

Model / Serial
Part Number: 05510988001. Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US and Canada.
Product Description
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK PLUS SET 6/70 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
Manufacturer
Roche Insulin Delivery Systems Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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