FDA (Devices) recall action 70369
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
Potential for leaking caused by insufficient bond between needleless device and female luer.
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.
Churchill Medical Systems is recalling 8-inch Standard Bore Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and the female luer.
Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.
Churchill Medical Systems is recalling 450 units of 4-inch Microbore T-Port Sets due to a potential leak caused by insufficient bonding between components.
Churchill Medical Systems is recalling 6,850 units of 7-inch Standard Bore High Pressure Extension Sets due to a potential leak caused by insufficient bonding.
Churchill Medical Systems is recalling 2,200 units of 4-inch Microbore Trifurcated Extension Sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.
Churchill Medical Systems is recalling 1,650 6-inch trifurcated sets with Bionectors due to a potential leak caused by insufficient bonding between the needleless device and the female luer.
Churchill Medical Systems is recalling 2,650 units of 4-inch trifurcated sets with Bionectors and check valves due to a potential for leaking caused by insufficient bonding.
Churchill Medical Systems is recalling 5,200 6-inch trifurcated extension sets due to a potential leak caused by insufficient bonding between the needleless device and female luer.
Churchill Medical Systems is recalling 1,050 bifurcated sets with check valves and Bionectors due to a potential for leaking caused by insufficient bonding.
Churchill Medical Systems is recalling 100 Bifurcated Extension Sets because a defect may cause leaking. The sets are used to administer medical fluids.
Churchill Medical Systems is recalling 2,350 units of 4-inch Microbore Double Lumen Sets due to a potential leak caused by an insufficient bond between the needleless device and the female luer.
Churchill Medical Systems is recalling 129,500 units of 7-inch High Pressure Sets with Bionector due to a potential for leaking caused by insufficient bonding.