MEDLINE INDUSTRIES, LP - Northfield: namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822

Hazard

Products have a lack of sterility assurance.

Details from the source

Reason for recall: Products have a lack of sterility assurance. Distribution: US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX. Quantity: 570 units Lot/code info: a) UDI/DI 10193489040456, Lot Numbers: 0000113192; b) UDI/DI 10193489044195, Lot Numbers: 0000113331; c) UDI/DI 10193489044386, Lot Numbers: 0000112999; d) UDI/DI 10193489044416, Lot Numbers: 0000113000; d) UDI/DI 10193489044935, Lot Numbers: 0000113187; e) UDI/DI f) UDI/DI g) UDI/DI h) UDI/DI i) UDI/DI j) UDI/DI k) UDI/DI l) UDI/DI m) UDI/DI n) UDI/DI o) UDI/DI p) UDI/DI q) UDI/DI

UPC codes

10193489040456, 10193489044195, 10193489044386, 10193489044416, 10193489044935

Source

Official record: FDA (Device enforcement) ↗

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