17 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001. 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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
FDA Recall
Terminated
·Kelyniam Global, Inc.·Product code GXN·June 10, 2017
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
FDA Recall
Terminated
·Kelyniam Global, Inc.·Product code GXN·June 10, 2017
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
FDA Recall
Terminated
·Kelyniam Global, Inc.·Product code GXN·June 10, 2017
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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510945001. AC FLEXLINK PLUS SET 10/40 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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510937001. AC FLEXLINK PLUS SET 10/100 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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK PLUS SET 8/70 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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA Recall
Terminated
·Kelyniam Global, Inc.·Product code GXN·June 10, 2017
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510953001. AC FLEXLINK PLUS SET 10/70 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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK PLUS SET 6/100 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
FDA Recall
Terminated
·Roche Insulin Delivery Systems Inc.·Product code FRN·February 24, 2011