Zimmer Surgical Inc: 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 Produ

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Canada and EMEA. Quantity: 45160 Lot/code info: 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)00889024378

UPC codes

00889024381162, 00889024378469, 00889024367173

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.