Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

Reason: Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

Code information: Lot Code: Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271022(10)79701946 ; Box (10-Pack) UDI (01)00889024380455(17)271022(10)79701946 ; Individual UDI (01)00889024376786(17)271022(10)79701946 ; Lot Number 79701946 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271028(10)79701947 ; Box (10-Pack) UDI (01)00889024380455(17)271028(10)79701947 ; Individual UDI (01)00889024376786(17)271028(10)79701947 ; Lot Number 79701947 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)271030(10)79701948 ; Box (10-Pack) UDI (01)00889024380455(17)271030(10)79701948 ; Individual UDI (01)00889024376786(17)271030(10)79701948 ; Lot Number 79701948 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280325(10)80555938 ; Box (10-Pack) UDI (01)00889024380455(17)280325(10)80555938 ; Individual UDI (01)00889024376786(17)280325(10)80555938 ; Lot Number 80555938 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280402(10)80555939 ; Box (10-Pack) UDI (01)00889024380455(17)280402(10)80555939 ; Individual UDI (01)00889024376786(17)280402(10)80555939 ; Lot Number 80555939 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280326(10)80555940 ; Box (10-Pack) UDI (01)00889024380455(17)280326(10)80555940 ; Individual UDI (01)00889024376786(17)280326(10)80555940 ; Lot Number 80555940 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280911(10)80581869 ; Box (10-Pack) UDI (01)00889024380455(17)280911(10)80581869 ; Individual UDI (01)00889024376786(17)280911(10)80581869 ; Lot Number 80581869 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280331(10)80581870 ; Box (10-Pack) UDI (01)00889024380455(17)280331(10)80581870 ; Individual UDI (01)00889024376786(17)280331(10)80581870 ; Lot Number 80581870 Model No. 60-4009-101-00 ; Case (20-pack) UDI (01)00889024382336(17)280402(10)80765021 ; Box (10-Pack) UDI (01)00889024380455(17)280402(10)80765021 ; Individual UDI (01)00889024376786(17)280402(10)80765021 ; Lot Number 80765021

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada and EMEA.