Recall Z-2651-2010
Gyrus Acmi, Incorporated · initiated August 6, 2010
Product
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
Codes / lots: All lots manufactured from June 1, 2007 through June 7, 2010.
Reason for recall
Lack of sterility assurance due to compromised package seals.
FDA-determined 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.
Details
- Recall number
- Z-2651-2010
- Initiated
- August 6, 2010
- Posted by FDA
- September 30, 2010
- Terminated
- January 26, 2012
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 4244 units
- 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
- Recalling firm
- Gyrus Acmi, Incorporated, Southborough, MA