International safety notice

Regarding the "Micro Feather Plastic Handle" (medical device), which is a component of the kit product manufactured and sold by our company. The manufacturer, Feather Safety Razor Co., Ltd., has announced that the blade of some products may fall off the handle. I received notification that a certain product has been shipped. In response to this notification, we cannot deny the possibility that similar defects may occur in kit products manufactured and sold by our company. Therefore, we have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Sep 1, 2023

Key facts

Title Regarding the "Micro Feather Plastic Handle" (medical device), which is a component of the kit product manufactured and sold by our company. The manufacturer, Feather Safety Razor Co., Ltd., has announced that the blade of some products may fall off the handle. I received notification that a certain product has been shipped. In response to this notification, we cannot deny the possibility that similar defects may occur in kit products manufactured and sold by our company. Therefore, we have decided to carry out a voluntary recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common Name: Single Use Class III Treatment Kit Sales name: Medline Surgical Custom Kit for Ophthalmology
Manufacturer Medline Japan LLC
Models KS2387604, KS2284083, KS2393198, KS2283387, M12OPH005C, KS2281617, KS2395912, M12OPH005D, KS2285043, KS2387744, KS2393403, KS2390896 and 1 more
Date Sep 1, 2023
Regulator page info.pmda.go.jp

At a glance

  • No Recall
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About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

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