CanadaVectorflow Antegrade Catheterization Product sold by Arrow International LLC (a Teleflex subsidiary) with catalogue numbers CS-15232-VF, CS-15232-VFIM, CS-15232-VFI, CS-15232-VFM, CS-15552-VFI, CS-15192-VFIM, CS-15192-VFM, CS-15422-VFI, CS-15192-VFI, and CS-15272-VF or CS-15312-VFI, and lot/serial numbers of more than 10 digits may be affected. The recall was initiated because a Merit 16F dual-valved splittable sheath introducer included in the kits may not split as intended due to a design-related issue. Contact the manufacturer for additional information.
What's being recalled
Companies: Arrow International Llc Subsidiary Of Teleflex Incorporated, 3015 Carrington Mill Blvd., Morrisville, North Carolina, United States, 27560.
How to identify it
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15232-VF *)
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15232-VFIM
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15232-VFI
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15232-VFM *)
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15552-VFI
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15192-VFIM
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15192-VFM *)
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15422-VFI
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15192-VFI
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15272-VF *)
Affected products: Vectorflow Antegrade Catheterization Product; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: CS-15312-VFI
The hazard
Teleflex has initiated a voluntary recall for certain lots of the above-mentioned products due to receipt of a supplier-initiated recall of the Merit 16f dual-valved splittable sheath introducer component, which is included in impacted arrow hemodialysis kits and sets. According to the recall notice issued by Merit Medical Systems, Inc.' (Merit), in some cases the sheath introducer may not split as intended due to a design related issue.
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)