38 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Enforcement
Class II
·Terminated·BioDerm, Inc.·June 18, 2014
BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Enforcement
Class II
·Terminated·BioDerm, Inc.·June 18, 2014
BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Enforcement
Class II
·Terminated·BioDerm, Inc.·June 18, 2014
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Recall
Terminated
·BioDerm, Inc.·Product code NEC·May 31, 2011
BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Recall
Terminated
·BioDerm, Inc.·Product code NEC·May 31, 2011
BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
FDA Recall
Terminated
·BioDerm, Inc.·Product code NEC·May 31, 2011
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·May 13, 2021
MEN'S LIBERTY ACUTE WITH CATHGRIP
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·June 29, 2022
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·June 17, 2022
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·June 29, 2022
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·May 13, 2021
RELIAFIT
FDA Adverse Event
Malfunction
·BIODERM, INC.·Product code NOA·December 24, 2014
MEN'S LIBERY EXTERNAL MALE CATHETER
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·November 1, 2014
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·May 4, 2022
MENS LIBERTY ACUTE WITH CATHGRIP
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·May 31, 2022
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·June 15, 2022
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·November 7, 2021
MEN'S LIBERTY EXTERNAL MALE CATHETER
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·August 9, 2014
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·April 22, 2019
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·May 7, 2019