FDA (Devices) recall action 83509

The Metrix Company recalled 8 products on 2019-10-09

The FDA (Devices) publishes a recall like this one as 8 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 8 pages.

Products: 8
Announced: 2019-10-09
Critical: 0
Units: 945,984

Why these products were recalled

Potential for leaking product

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.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2019-10-09
FDA Recalls ExactaMix IV Bags Due to Potential Leaking
The FDA is recalling 175,392 ExactaMix IV bags due to a potential for leaking. The bags are used for intravenous admixture programs.
Product
ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar f
Category
Distribution
3 states
HighFDA (Devices)··2019-10-09
Metrix Secure EVA IV Bags Recalled for Potential Leaking
The Metrix Company is recalling 1,512 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide in the US.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of
Category
Distribution
3 states
HighFDA (Devices)··2019-10-09
Metrix Secure EVA Dual Chamber Container Recall for Leaking
The Metrix Company is recalling 4,284 Secure EVA dual chamber containers due to a potential for leaking. The affected bags are used for intravenous admixtures.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of
Category
Distribution
3 states
HighFDA (Devices)··2019-10-09
Baxter ExactaMix IV Bags Recalled for Potential Leaking
The Metrix Company is recalling Baxter ExactaMix IV bags due to a potential for leaking. The recall covers 332,640 units distributed nationwide.
Product
ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar f
Category
Distribution
3 states
ModerateFDA (Devices)··2019-10-09
Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking Risk
The Metrix Company is recalling 1,596 Secure EVA dual chamber IV bags due to a potential for leaking. The affected bags were distributed nationwide.
Product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of
Category
Distribution
3 states
HighFDA (Devices)··2019-10-09
Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking
The Metrix Company is recalling 14,1120 Secure EVA dual chamber IV bags due to a potential for leaking. The affected products were distributed in the US and Canada.
Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The u
Category
Distribution
3 states
HighFDA (Devices)··2019-10-09
Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking
The Metrix Company is recalling 234,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed nationwide in the US.
Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The u
Category
Distribution
3 states
HighFDA (Devices)··2019-10-09
Metrix Secure EVA IV Bags Recalled for Potential Leaking
The Metrix Company is recalling 54,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed in the US and Canada.
Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The u
Category
Distribution
3 states