Devices

Device Recall EpiFLO SD

Model / Serial
A total of 18 lot codes were distributed. They are as follows: 23105A, 31805A, 34905A, 01006A, 00906A, 35505A, 34705A, 00606A, 35005A, 35305A, 01006A, 01706A, 01206A, 02006A, 02306A, 01806A, 01106A, and 30105A
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
The product was distributed to customers located in the following states: IN, MD, TX, MA, MI, MN, OH, FL, and NB.
Product Description
Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery.
Manufacturer
Ogenix Corporation
1 Event
- Recall of Device Recall EpiFLO SD

Manufacturer

Ogenix Corporation

Manufacturer Address
Ogenix Corporation, 23230 Chagrin Blvd, Suite 950, Cleveland OH 44122-5461
Source
USFDA

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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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