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
This recall has been terminated (originally issued September 30, 2010).
- Company
- Gyrus Acmi, Incorporated
- Recall Initiated
- August 6, 2010
- Posted
- September 30, 2010
- Terminated
- January 26, 2012
- Recall Number
- Z-2651-2010
- Quantity
- 4244 units
- Firm Location
- Southborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of sterility assurance due to compromised package seals.
Distribution
Worldwide In the United States: AL, AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV and the District of Columbia. Foreign: UK, TAIWAN, SOUTH KOREA, GERMANY, CANADA, AUSTRALIA, SPAIN, ITALY, ISRAEL, NORWAY, LITHUANIA, SWEDEN, SWITZERLAND, SAUDI ARABIA, TURKEY, and GREAT BRITAIN
Lot / Code Info
All lots manufactured from June 1, 2007 through June 7, 2010.
Root Cause
Packaging
Action Taken
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.