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
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 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
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. 60-4009-101-00Model Case (20-pack) UDI (01)00889024382336(17)271022(10)79701946Model Box (10-Pack) UDI (01)00889024380455(17)271022(10)79701946Model Individual UDI (01)00889024376786(17)271022(10)79701946Model Lot Number 79701946 Model No. 60-4009-101-00Model Case (20-pack) UDI (01)00889024382336(17)271028(10)79701947Model Box (10-Pack) UDI (01)00889024380455(17)271028(10)79701947Model Individual UDI (01)00889024376786(17)271028(10)79701947Model Lot Number 79701947 Model No. 60-4009-101-00Model Case (20-pack) UDI (01)00889024382336(17)271030(10)79701948Model Box (10-Pack) UDI (01)00889024380455(17)271030(10)79701948Model Individual UDI (01)00889024376786(17)271030(10)79701948Model Lot Number 79701948 Model No. 60-4009-101-00Model Case (20-pack) UDI (01)00889024382336(17)280325(10)80555938Model Box (10-Pack) UDI (01)00889024380455(17)280325(10)80555938Model Individual UDI (01)00889024376786(17)280325(10)80555938Model Lot Number 80555938 Model No. 60-4009-101-00Model Case (20-pack) UDI (01)00889024382336(17)280402(10)80555939Model Box (10-Pack) UDI (01)00889024380455(17)280402(10)80555939Model Individual UDI (01)00889024376786(17)280402(10)80555939Model Lot Number 80555939 Model No. 60-4009-101-00Model Case (20-pack) UDI (01)00889024382336(17)280326(10)80555940Model Box (10-Pack) UDI (01)00889024380455(17)280326(10)80555940Model Individual UDI (01)00889024376786(17)280326(10)80555940Model Lot Number 80555940 Model No. 60-4009-101-00UPC 00889024382336UPC 00889024380455UPC 00889024376786Would you have heard about this one?
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