CanadaRocket® Seldinger Chest Drain Kit (Rocket Medical also trading as Nusurgix) with lot/serial numbers 497344, 497665, 497012, 497561, 498069, 497516, and 497077 and catalogue numbers R54544-12-PK, R54544-12-SG, R54544-18-SG, R54549-20-PK, R54549-16-PK is affected. The instructions for use incorrectly state that either suturing or a fixation device may be used when suturing should be mandatory; an updated IFU stating suturing is mandatory is being provided to customers. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Rocket Medical Also Trading As Nusurgix, Sedling Road, Washington, Tyne And Wear, United Kingdom, NE38 9BZ.
How to identify it
Affected products: Rocket® Seldinger Chest Drain Kit; Lot or serial number: 497344; Model or catalogue number: R54544-12-PK
Affected products: Rocket® Seldinger Chest Drain Kit; Lot or serial number: 497665; Model or catalogue number: R54544-12-SG
Affected products: Rocket® Seldinger Chest Drain Kit; Lot or serial number: 497012; Model or catalogue number: R54544-18-SG
Affected products: Rocket® Seldinger Chest Drain Kit; Lot or serial number: 497561; Model or catalogue number: R54544-18-SG
Affected products: Rocket® Seldinger Chest Drain Kit; Lot or serial number: 498069; Model or catalogue number: R54544-18-SG
Affected products: Rocket® Seldinger Chest Drain Kit; Lot or serial number: 497516; Model or catalogue number: R54549-20-PK
Affected products: Rocket® Seldinger Chest Drain Kit; Lot or serial number: 497077; Model or catalogue number: R54549-16-PK
The hazard
IFU incorrectly states suturing or fixation device to be used. Suturing should be mandatory. Updated IFU which states suturing is mandatory is being provided to customers.
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)