FDA (Devices) recall action 82512
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.
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
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.
OriGen Biomedical is recalling 260 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection caused by adhesive failure.
OriGen Biomedical is recalling 72 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection from the hub caused by adhesive failure.
OriGen Biomedical is recalling 66 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub if clamped improperly.
OriGen Biomedical is recalling 145 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub.
OriGen Biomedical is recalling 66 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of the clear tube disconnecting from the hub.
OriGen Biomedical is recalling 61 units of ECMO Reinforced Dual Lumen Cannulas due to a risk of tube disconnection from the hub caused by adhesive failure.