Bioderm, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Bioderm, Inc. makes
Bioderm, Inc. manufactures wound dressings and incontinence devices, including foam wound dressings, hydrogel island dressings, composite wound dressings, hydrocolloid wound dressings, thin film wound dressings, transparent film dressings, and a male external incontinence device.
The company's products are listed in the FDA 510(k) registry and are classified as Class I and Class U devices. Bioderm, Inc. is based in the US.
Catalogue
Search and filter all 14 devicesFDA recalls
FDA recall records list 3 recalls initiated by Bioderm, Inc., initiated on 2011-05-31. By recorded status: 3 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 31 May 2011 Z-1742-2014 Class II Terminated On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.
Full distribution text
- 31 May 2011 Z-1743-2014 Class II Terminated On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.
Full distribution text
- 31 May 2011 Z-1744-2014 Class II Terminated On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers.
Full distribution text
- 31 May 2011 Z-1742-2014 Class II Terminated On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.
Frequently asked questions
How many devices does Bioderm, Inc. have in the registry?
The registry currently lists 14 devices for Bioderm, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioderm, Inc.'s devices?
Among its 14 most recently registered devices, Bioderm, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Bioderm, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Bioderm, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Bioderm, Inc.?
FDA recall records list 3 recalls initiated by Bioderm, Inc., the most recent initiated on 31 May 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bioderm, Inc. in the registry?
The most recently registered devices listed for Bioderm, Inc. include BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE, BIODERM FOAM WOUND DRESSING, BIODERM MEDICAL FOAM WOUND DRESSING and BIODERM MEDICAL HYDROGEL ISLAND DRESSING.