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KIATO

ADITYA DISPOMED PRODUCTS PRIVATE LIMITED · Model 10 · UDI-DI 08902895111101

GES

510(k) clearances

970

Adverse events

Recalls

304

Facilities

Description

KIATO Sterile CE carbon Steel Surgical Blade Box of 100 size 10. Sterilized by Gamma Irradiation.

Recalls

Date	Firm	Reason
2022-10-27	Southmedic, Inc.	Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold
2016-06-27	Aspen Surgical Puerto Rico Corp.	After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil
2012-08-15	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	Potential for bent tips.
2012-08-15	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	Potential for bent tips.
2012-08-15	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	Potential for bent tips.
2012-08-15	Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.	Potential for bent tips.
2009-09-29	Merit Medical Systems, Inc.	Potential sterility breach caused by excessive shipment damage.
2008-11-17	Miltex, Inc.	Blade may break: Over milling of the blade resulted in tip more narrow than specified.
2007-08-10	Becton Dickinson & Company	Complaints received of rust on the blades of BD Bard-Parker Surgical blades.
2007-08-10	Becton Dickinson & Company	Complaints received of rust on the blades of BD Bard-Parker Surgical blades.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.