HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF 7013-5050, QTY (1), STERILE EO, HEMOSTAT

FDA device recall Z-2595-2010 · posted 2010-09-28 · Terminated

Recall details

Recalling firm

Hemostatix Medical Technologies LLC

Reason for recall

Lack of sterility assurance

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GEI

Quantity affected

219 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.

Date initiated

2010-07-27

Date posted

2010-09-28

Date terminated

2010-11-29

Location

Bartlett, TN

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