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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
The Metrix Company is recalling Baxter ExactaMix, Model H938905, Empty EVA Dual Chamber Containers with Screw Connectors (250 ml/1250 ml). The recall involves 332,640 units of the product, which is used in intravenous admixture programs for the storage and delivery of parenteral admixtures.
The recall was initiated due to a potential for leaking product. The affected units were distributed nationwide, including the states of Pennsylvania, Massachusetts, Illinois, and California.
Consumers and healthcare facilities should stop using the recalled product and contact The Metrix Company for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- The Metrix Company
- Category
- Medical Device — IV Bags
- Hazard
- Affected units
- 332,640
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: H938905 63630-A1769
- H938905 63630-A1771
- H938905 63630-A1773
- H938905 63630-A2647
- H938905 63630-A2649
- H938905 63630-A2651
- H938905 63630-A2655
- H938905 63630-A2657
- H938905 63630-A2659
- H938905 63630-A2661
- H938905 63630-A3950
- H938905 63630-A3952
- H938905 63630-A3954
- H938905 63630-A3956
- H938905 63630-A3957
- H938905 63630-A3959
- H938905 63630-A3961
- H938905 63630-A3963
- H938905 63630-A3965
- H938905 63630-A3968
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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