International safety notice
During manufacturing, it was discovered that some products may have leaks within the catheter bifurcation. In the approved product, a gap is created between the lumens within the branch, so when liquid is flowed from one branch pipe, Liquid that would normally flow to the distal end of the catheter may flow not only to the distal end of the catheter but also to the other branch tube. Confirmed. We have decided to carry out a voluntary recall of the products.
Japan / PMDA Recalls · JPN · Jun 15, 2022
Key facts
| Title | During manufacturing, it was discovered that some products may have leaks within the catheter bifurcation. In the approved product, a gap is created between the lumens within the branch, so when liquid is flowed from one branch pipe, Liquid that would normally flow to the distal end of the catheter may flow not only to the distal end of the catheter but also to the other branch tube. Confirmed. We have decided to carry out a voluntary recall of the products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Emergency blood access catheter Sales name: Palindrome Precision |
| Manufacturer | Covidien Japan Co., Ltd. |
| Models | 1917600142, 1916500104, 1917600118, 1716500190, 1801700121, 1815800084, 1808600074, 1725600118, 1801700122, 1909400128, 1733700132, 1908400308 and 123 more |
| Date | Jun 15, 2022 |
| 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