FDA (Devices) recall action 95499
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
A limited number of IV bags have been found to leak during filling.
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.
The Metrix Company is recalling SECURE 1000 mL empty IV containers because a limited number were found to leak during filling.
The Metrix Company is recalling a limited number of VYGON 100 mL empty IV containers (Lot Numbers 62040-A8375 and 62040-A8432) due to leakage found during the filling process. The affected containers are distributed in multiple U.S. states and Canada.
The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.
The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.
The Metrix Company is recalling SECURE 100 mL empty EVA containers for IV use due to leaking discovered during filling. Approximately 2,229 cases were distributed to healthcare facilities in the US and Canada.
The Metrix Company is recalling Imed EVA 500 mL IV bags because a limited number have been found to leak during filling. Affected lots were distributed nationwide in the U.S. and Canada.
The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in Canada.
The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.
The Metrix Company is recalling SECURE 50 mL EVA containers used for intravenous fluid administration because a limited number of pouches have been found to leak during filling. Affected products were distributed nationwide and to Canada.
The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous fluid administration.
The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.
The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.
The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.
The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.
The Metrix Company is recalling SECURE 500 mL EVA containers (REF 66050) used for intravenous administration because a limited number have been found to leak during filling. Affected lots were distributed nationwide and to Canada.
The Metrix Company is recalling Imed EVA IV bags due to leakage discovered during the filling process. A limited number of bags were found to leak, potentially affecting the safety of intravenous therapy.