FDA Device

GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS MEDICAL LIMITED, FORTRAN ROAD, ST. MELLONS, CARDIFF, CF3 0LT, UK

Hazard

Lack of sterility assurance due to compromised package seals.

What You Should Do

Remedy

The firm initiated their recall to their direct accounts by Priority Mail with delivery confirmation on 08/06/2010. The letter requested return of the product and was extended to the retail level.

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Products

GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA, MANUFACTURED FOR; GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104, USA, EC REP, GYRUS ME
Brand
Gyrus Acmi, Incorporated
UPC
All lots manufactured from June 1, 2007 through June 7, 2010.

Units Affected

4244 units

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