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U.S. Department of Health and Human Services

Class 2 Device Recall MODEL P8400 HANDLE

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  Class 2 Device Recall MODEL P8400 HANDLE see related information
Date Initiated by Firm July 27, 2010
Date Posted September 28, 2010
Recall Status1 Terminated 3 on November 29, 2010
Recall Number Z-2596-2010
Recall Event ID 56366
510(K)Number K091107  K033089  K902307  
Product Classification electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product 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.
Code Information LOT HMT0647
Recalling Firm/
Manufacturer		 Hemostatix Medical Technologies LLC
8400 Wolf Lake Dr Ste 109
Bartlett TN 38133-4189
For Additional Information Contact Brad Beale
901-261-0012
Manufacturer Reason
for Recall		 Lack of sterility assurance
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 40 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GYRUS ENT L.L.C.
510(K)s with Product Code = GEI and Original Applicant = HEMOSTATIC SURGERY CORP.
510(K)s with Product Code = GEI and Original Applicant = HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
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