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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leaking) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 175,392 units of ExactaMix, Model H938901, Empty EVA Dual Chamber Containers with Screw Connectors. These containers are manufactured by The Metrix Company and are used in intravenous admixture programs for the storage and delivery of parenteral admixtures.
The recall is being conducted because of a potential for the product to leak. The affected products were distributed nationwide in the United States, including in the states of Pennsylvania, Massachusetts, Illinois, and California.
Healthcare facilities and pharmacies should stop using the affected ExactaMix containers and contact The Metrix Company for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- 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
- Manufacturer
- The Metrix Company
- Category
- Medical Device — IV Bags
- Hazard
- Affected units
- 175,392
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: H938901 63615-A1768
- H938901 63615-A1770
- H938901 63615-A1772
- H938901 63615-A2648
- H938901 63615-A2650
- H938901 63615-A2652
- H938901 63615-A2653
- H938901 63615-A2654
- H938901 63615-A2656
- H938901 63615-A2658
- H938901 63615-A2660
- H938901 63615-A2662
- H938901 63615-A3951
- H938901 63615- A3953
- H938901 63615-A3955
- H938901 63615-A3958
- H938901 63615-A3960
- H938901 63615-A3962
- H938901 63615-A3964
- H938901 63615-A3966
Distribution
Part of a larger recall action
This product is one of 8 recalled by The Metrix Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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