International Medical Devices Database

Manufacturer Address
Embeem Inc., 18 Ireland Brook Dr, N Brunswick NJ 08902-4761
Source
USFDA
1 Event
- Recall of Device Recall HiZel, trayless, wound dressing, sterile

One device in the database

Device Recall HiZel, trayless, wound dressing, sterile

Model / Serial
There are no lot codes. The firm is recalling all trayless product from its shipment dated 3/28/2006.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
There are 47 customers which includes two large distributors/accounts and the rest are internet individual purchasers. These internet purchases amounts are 6 to 18 pieces at a time. There are no government accounts and no international accounts generating from EMBEEM.
Product Description
HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4'', 2.4 x 4.7'', & 4.7 x 4.7''. Product is a transparent, flexible sheet. Packaged in a peelable pouch.

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Disclaimer

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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Embeem Inc.

One device in the database

Device Recall HiZel, trayless, wound dressing, sterile