FDA (Devices) recall action 96783
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.
Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.
Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.
Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.
Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.