CanadaA.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors are affected; single-hose units include lot/serial numbers 79701948, 80555938, 79701947, 80581870, 80765021, 79701946, 80555940, 80555939, 80581869 (model/catalogue 60-4009-101-00) and dual-hose 20-packs (model/catalogue 60-1812-101-00) have more than 10 lot/serial numbers — contact the manufacturer for specific serials. They were recalled after a complaint reported wrinkles in the sterile pouch seal and internal testing found potential sterility breach in 0.92% of inspected units due to visual seal nonconformities. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Zimmer Surgical, Inc. Also Trading As Relign Corporation, 200 W Ohio Avenue, Dover, Ohio, United States, 44622.
How to identify it
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 79701948; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 80555938; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 79701947; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 80581870; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 80765021; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 79701946; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 80555940; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 80555939; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Single Hose With CPC Connectors; Lot or serial number: 80581869; Model or catalogue number: 60-4009-101-00
Affected products: A.T.S® 4000 TS Tourniquet Systems Dual Hose With CPC Connectors, 20-Pack; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 60-1812-101-00
The hazard
Zimmer Biomet is conducting a medical device recall for A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors. One (1) complaint was received with no clinical impact reporting that wrinkles were identified in the sealing area of the sterile pouch. Subsequent seal integrity testing conducted internally showed potential sterility breach in 0.92% of inspected units that had visual seal nonconformities. The devices are distributed in cases (CS) of 20 units. Inside each case are two boxes (BX) of 10 units each.
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)