CanadaSingle Use Ligating Device PolyLoop™ (model/catalogue HX-400U-30, all lots) from Olympus Medical Systems Corp. is affected. The ligation loop may fail to release or detach as expected, potentially becoming unintentionally anchored around patient anatomy; users are reminded to adhere to the warnings and cautions in the instructions for use. Contact the manufacturer for additional information.
What's being recalled
Companies: Olympus Medical Systems Corp., 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507.
How to identify it
Affected products: Single Use Ligating Device PolyLoop™; Lot or serial number: All lots.; Model or catalogue number: HX-400U-30
The hazard
Olympus received complaints indicating that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally anchored in place around patient anatomy. Users are reminded to adhere to the warnings and cautions statements that are present in the instructions for use.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)