International Medical Devices Database

Manufacturer Address
McKesson General Medical Corporation, 5601 Eastport Boulevard, Richmond VA 23231
Source
USFDA
1 Event
- Recall of PROLENE

One device in the database

PROLENE

Model / Serial
All codes, including the lots that the manufacturer of authentic product specified as counterfeit, RBE609 EXP1/07 and RJJ130 EXP 7/07.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Counterfeit and authentic product had been shipped to 221 hospitals and surgery centers in the continental US.
Product Description
PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton

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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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McKesson General Medical Corporation

One device in the database

PROLENE