International safety notice
A guide guide is used during the placement of the "Standard Peg System (Push method)" (hereinafter referred to as "this product") overseas. In response to an increase in complaints that the ear does not pass through the tube lumen (hereinafter referred to as "this event"), we conducted a detailed investigation. However, it was discovered that the inner lumen of the tube connector may be blocked in some batches, so this product has been discontinued. We have decided to carry out a voluntary recall of certain lots.
Japan / PMDA Recalls · JPN · Feb 20, 2024
Key facts
| Title | A guide guide is used during the placement of the "Standard Peg System (Push method)" (hereinafter referred to as "this product") overseas. In response to an increase in complaints that the ear does not pass through the tube lumen (hereinafter referred to as "this event"), we conducted a detailed investigation. However, it was discovered that the inner lumen of the tube connector may be blocked in some batches, so this product has been discontinued. We have decided to carry out a voluntary recall of certain lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Long-term use enteral feeding kit Sales name: Standard Peg System |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | M00509191, 32234291 |
| Date | Feb 20, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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