Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual 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. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271 ; Box (10-Pack) UDI (01)00889024378469(17)271125(10)78938271 ; Individual UDI (01)00889024367173(17)271125(10)78938271 ; Lot Number 78938271 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271126(10)78938272 ; Box (10-Pack) UDI (01)00889024378469(17)271126(10)78938272 ; Individual UDI (01)00889024367173(17)271126(10)78938272 ; Lot Number 78938272 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271127(10)78938273 ; Box (10-Pack) UDI (01)00889024378469(17)271127(10)78938273 ; Individual UDI (01)00889024367173(17)271127(10)78938273 ; Lot Number 78938273 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280206(10)80555986 ; Box (10-Pack) UDI (01)00889024378469(17)280206(10)80555986 ; Individual UDI (01)00889024367173(17)280206(10)80555986 ; Lot Number 80555986 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280102(10)80555987 ; Box (10-Pack) UDI (01)00889024378469(17)280102(10)80555987 ; Individual UDI (01)00889024367173(17)280102(10)80555987 ; Lot Number 80555987 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280210(10)80555988 ; Box (10-Pack) UDI (01)00889024378469(17)280210(10)80555988 ; Individual UDI (01)00889024367173(17)280210(10)80555988 ; Lot Number 80555988 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280214(10)80555989 ; Box (10-Pack) UDI (01)00889024378469(17)280214(10)80555989 ; Individual UDI (01)00889024367173(17)280214(10)80555989 ; Lot Number 80555989 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280217(10)80555990 ; Box (10-Pack) UDI (01)00889024378469(17)280217(10)80555990 ; Individual UDI (01)00889024367173(17)280217(10)80555990 ; Lot Number 80555990 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280225(10)80568849 ; Box (10-Pack) UDI (01)00889024378469(17)280225(10)80568849 ; Individual UDI (01)00889024367173(17)280225(10)80568849 ; Lot Number 80568849 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280409(10)82010858 ; Box (10-Pack) UDI (01)00889024378469(17)280409(10)82010858 ; Individual UDI (01)00889024367173(17)280409(10)82010858 ; Lot Number 82010858 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280403(10)82010859 ; Box (10-Pack) UDI (01)00889024378469(17)280403(10)82010859 ; Individual UDI (01)00889024367173(17)280403(10)82010859 ; Lot Number 82010859 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280415(10)82196691 ; Box (10-Pack) UDI (01)00889024378469(17)280415(10)82196691 ; Individual UDI (01)00889024367173(17)280415(10)82196691 ; Lot Number 82196691 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280419(10)82196692 ; Box (10-Pack) UDI (01)00889024378469(17)280419(10)82196692 ; Individual UDI (01)00889024367173(17)280419(10)82196692 ; Lot Number 82196692 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280423(10)82331021 ; Box (10-Pack) UDI (01)00889024378469(17)280423(10)82331021 ; Individual UDI (01)00889024367173(17)280423(10)82331021 ; Lot Number 82331021 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280427(10)82331022 ; Box (10-Pack) UDI (01)00889024378469(17)280427(10)82331022 ; Individual UDI (01)00889024367173(17)280427(10)82331022 ; Lot Number 82331022 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280501(10)82418900 ; Box (10-Pack) UDI (01)00889024378469(17)280501(10)82418900 ; Individual UDI (01)00889024367173(17)280501(10)82418900 ; Lot Number 82418900 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280507(10)82418901 ; Box (10-Pack) UDI (01)00889024378469(17)280507(10)82418901 ; Individual UDI (01)00889024367173(17)280507(10)82418901 ; Lot Number 82418901 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280513(10)82639501 ; Box (10-Pack) UDI (01)00889024378469(17)280513(10)82639501 ; Individual UDI (01)00889024367173(17)280513(10)82639501 ; Lot Number 82639501 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280516(10)82761025 ; Box (10-Pack) UDI (01)00889024378469(17)280516(10)82761025 ; Individual UDI (01)00889024367173(17)280516(10)82761025 ; Lot Number 82761025 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280529(10)83343102 ; Box (10-Pack) UDI (01)00889024378469(17)280529(10)83343102 ; Individual UDI (01)00889024367173(17)280529(10)83343102 ; Lot Number 83343102 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280820(10)84859541 ; Box (10-Pack) UDI (01)00889024378469(17)280820(10)84859541 ; Individual UDI (01)00889024367173(17)280820(10)84859541 ; Lot Number 84859541 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280902(10)84859542 ; Box (10-Pack) UDI (01)00889024378469(17)280902(10)84859542 ; Individual UDI (01)00889024367173(17)280902(10)84859542 ; Lot Number 84859542 Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)281112(10)86156905 ; Box (10-Pack) UDI (01)00889024378469(17)281112(10)86156905 ; Individual UDI (01)00889024367173(17)281112(10)86156905 ; Lot Number 86156905

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