MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
Recall
- Recall Number
- Z-2596-2010
- Event Number
- 56366
- Firm
- Hemostatix Medical Technologies LLC
- FEI Number
- 3006119098
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 27, 2010
- Posted
- September 28, 2010
- Terminated
- November 29, 2010
- Address
- 8400 Wolf Lake Dr, Ste 109, Bartlett, TN, 38133-4189
Description
MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel while minimizing blood loss by simultaneously sealing blood vessels as they are cut, with minimum damage to surrounding tissue and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
Lack of sterility assurance
On July 27, 2010, the firm, Hemostatix Medical Technologies, LLC, notified their international distributor in Japan of the recall by email. Hemostatix sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 29, 2010, to U.S. customers delivered via FedEx Priority Overnight. All non-responding customers were to be notified by telephone after 2 weeks. The other international customer, Italy, were to be notified by email on July 30, 2010. The letter describes the product, problem and action to be taken by customers. The customers were instructed to immediately check their inventory and remove any affected product found; ensure that satellite facilities/clinics receive the recall notice; complete and return the Recall Response Form via fax to Hemostatix's international fax number at 901-261-0017, and contact the Customer Care Department's recall hotline at 901-261-0012 for further instructions, if they do have affected stock. If you have any questions or concerns, please feel free to contact our Customer Care Department at: 1-800-722-5735 in the USA or 1-901-261-0012 outside the USA.
Worldwide distribution: USA including CA, GA, LA, MA, MD, MO, NC, OH, OR, PA, SC, TX, VA, and WI; and countries of Japan and Italy.
40 units