Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0610-2007

19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd...

Alcon Laboratories / initiated 2007-01-18 / Terminated / root cause: labeling and UDI

Alcon Research, Ltd began a recall of 19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203 on . The reason FDA records is "Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula Plugs". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0610-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Alcon Laboratories
Product
19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.
Product code
NGY Cannula, Trocar, Ophthalmic
Reason for recall
Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Canula Plugs.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Recalled by letter on January 22, 2007.
Quantity in commerce
15 units.
Distribution
Nationwide- Hospitals in MD and MN.
Product codes and lots
Lot F58507