CanadaCincinnati Surgical branded blades and scalpels (catalogue numbers 0022, 0121, 0222, 44, 0270, 0111, 0260CS, 0110) with lot or serial numbers of more than 10 numbers are affected. They were recalled because unlicensed medical devices were sold into Canada — Cincinnati Surgical holds an MDEL for class I and II devices but sold some branded devices into Canada without the required MDL for its class II product. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Cincinnati Surgical Co., Inc., 11331 Grooms Road, Blue Ash, Ohio, United States, 45242.
How to identify it
Affected products: Cincinnati Surgical Branded Blades And Scalpels; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0022
Affected products: Cincinnati Surgical Branded Blades And Scalpels; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0121
Affected products: Cincinnati Surgical Branded Blades And Scalpels; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0222
Affected products: Cincinnati Surgical Branded Blades And Scalpels; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 44
Affected products: Cincinnati Surgical Branded Blades And Scalpels; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0270
Affected products: Cincinnati Surgical Branded Blades And Scalpels; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0111
Affected products: Cincinnati Surgical Branded Blades And Scalpels; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0260CS
Affected products: Cincinnati Surgical Branded Blades And Scalpels; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 0110
The hazard
Unlicensed medical devices were sold into Canada - Swann Morton manufactures Cincinnati surgical branded medical devices. Cincinnati surgical holds an MDEL for class I and II devices, but sold some Cincinnati surgical branded devices into Canada without the required MDL for its class II product.
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)