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
Zimmer Surgical Inc
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Lot Code: Model No. 60-1812-101-00Model Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271Model Box (10-Pack) UDI (01)00889024378469(17)271125(10)78938271Model Individual UDI (01)00889024367173(17)271125(10)78938271Model Lot Number 78938271 Model No. 60-1812-101-00Model Case (20-pack) UDI (01)00889024381162(17)271126(10)78938272Model Box (10-Pack) UDI (01)00889024378469(17)271126(10)78938272Model Individual UDI (01)00889024367173(17)271126(10)78938272Model Lot Number 78938272 Model No. 60-1812-101-00Model Case (20-pack) UDI (01)00889024381162(17)271127(10)78938273Model Box (10-Pack) UDI (01)00889024378469(17)271127(10)78938273Model Individual UDI (01)00889024367173(17)271127(10)78938273Model Lot Number 78938273 Model No. 60-1812-101-00Model Case (20-pack) UDI (01)00889024381162(17)280206(10)80555986Model Box (10-Pack) UDI (01)00889024378469(17)280206(10)80555986Model Individual UDI (01)00889024367173(17)280206(10)80555986Model Lot Number 80555986 Model No. 60-1812-101-00Model Case (20-pack) UDI (01)00889024381162(17)280102(10)80555987Model Box (10-Pack) UDI (01)00889024378469(17)280102(10)80555987Model Individual UDI (01)00889024367173(17)280102(10)80555987Model Lot Number 80555987 Model No. 60-1812-101-00Model Case (20-pack) UDI (01)00889024381162(17)280210(10)80555988Model Box (10-Pack) UDI (01)00889024378469(17)280210(10)80555988Model Individual UDI (01)00889024367173(17)280210(10)80555988Model Lot Number 80555988 Model No. 60-1812-101-00UPC 00889024381162UPC 00889024378469UPC 00889024367173Would you have heard about this one?
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