Z-2596-2010

MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1)...

Name: Z-2596-2010 MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1)...
Creator: Hemostatix Medical Technologies LLC
Published: 2010-07-27
License: https://open.fda.gov/license/

Hemostatix Medical Technologies, LLC / initiated 2010-07-27 / Terminated / root cause: sterility

FDA source

Hemostatix Medical Technologies LLC began a recall of MODEL P8400 HANDLE WITH INTEGRATED CABLE, FOR USE WITH MODEL P8400 CONTROLLER, REF 7013-8050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC... on 2010-07-27. The reason FDA records is "Lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2596-2010
Status: Terminated
Initiated: 2010-07-27
Posted: 2010-09-28
Terminated: 2010-11-29
Recalling firm: Hemostatix Medical Technologies, LLC
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Lack of sterility assurance
Root cause tag: sterility
FDA root cause: 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.
Product codes and lots: LOT HMT0647

Product code GEI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)