CanadaBioFlo Dialysis Catheter With Endexo Technology (catalogue numbers H965103028041, H965103028051, H965103028061, H965103028070, H965103028090, H965103028080, H965103028031; all lots) is affected. Merit says the included 16F dual‑valved splittable sheath introducer may not split as intended, prompting customer complaints and some patient injuries and risking hemorrhage, foreign bodies and procedure delay; customers should immediately discontinue use of the 16F sheath introducer and destroy it at point of use and contact the manufacturer for more information; other products included with the sheath introducer may continue to be used.
What's being recalled
Companies: Merit Medical Systems Inc., 1600 West Merit Parkway, South Jordan, Utah, United States, 84095.
How to identify it
Affected products: BioFlo Dialysis Catheter With Endexo Technology; Lot or serial number: All lots.; Model or catalogue number: H965103028041
Affected products: BioFlo Dialysis Catheter With Endexo Technology; Lot or serial number: All lots.; Model or catalogue number: H965103028051
Affected products: BioFlo Dialysis Catheter With Endexo Technology; Lot or serial number: All lots.; Model or catalogue number: H965103028061
Affected products: BioFlo Dialysis Catheter With Endexo Technology; Lot or serial number: All lots.; Model or catalogue number: H965103028070
Affected products: BioFlo Dialysis Catheter With Endexo Technology; Lot or serial number: All lots.; Model or catalogue number: H965103028090
Affected products: BioFlo Dialysis Catheter With Endexo Technology; Lot or serial number: All lots.; Model or catalogue number: H965103028080
Affected products: BioFlo Dialysis Catheter With Endexo Technology; Lot or serial number: All lots.; Model or catalogue number: H965103028031
The hazard
Merit Medical Systems, Inc. (Merit) is conducting a voluntary recall of the Merit 16F Dual-valved Splittable Sheath Introducer due to a design defect. Specifically, the sheath introducer may not split as intended. This sheath introducer is used in several Merit finished devices (e.g. BioFlo DuraMax catheter).
Merit has received customer complaints related to this issue, some of which involve patient injury. Failure of the sheath introducer to split as intended may result in hemorrhage, foreign bodies, and procedure delay.
Merit is requesting customers to immediately discontinue the use of the 16F dual-valved splittable sheath introducer and destroy the sheath introducer at point of use. The other products included with the sheath introducer may continue to be used.
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)