CanadaHemodialysis Opening (Hemodialyse Ouverture) Packs, model/catalogue number 17-7560A and affected lot or serial numbers listed as “more than 10 numbers,” sold by Cardinal Health 200, LLC (Cardinal Health), are included in the recall. The recall was issued after ICU Medical Inc. reported lot-specific issues with the Tego™ silicone seal. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Cardinal Health 200, Llc Also Trading As Cardinal Health, 3651 Birchwood Drive, Waukegan, Illinois, United States, 60085.
How to identify it
Affected products: Hemodialysis Opening (Hemodialyse Ouverture) Packs; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 17-7560A
The hazard
Cardinal Health was recently informed of a medical device recall from ICU Medical Inc. concerning the Tego™ silicone seal. The recall is being issued due to lot-specific issues with the silicone seal on the Tego device.
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)