International safety notice

We have received a report from a domestic medical institution that some products have sterile packaging that does not adhere properly. However, it is possible that a similar defect may occur with a specific lot of the product number (40430) shipped to the domestic market. Since we cannot deny this possibility, we have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Dec 12, 2022

Key facts

Title We have received a report from a domestic medical institution that some products have sterile packaging that does not adhere properly. However, it is possible that a similar defect may occur with a specific lot of the product number (40430) shipped to the domestic market. Since we cannot deny this possibility, we have decided to carry out a voluntary recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Medical sponge Sales name: Eyedrain
Manufacturer Beaver Visitec International Japan Co., Ltd.
Models 21M3820, 40430, 21L3403
Date Dec 12, 2022
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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

Browse all International device safety notices