Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk
Baxter Healthcare is recalling 456,071 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.
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 the hazard involves a risk of harm (leaking) for a medical device where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Baxter Healthcare Corporation is recalling 456,071 units of Exactamix Empty EVA Bags, 2000 mL. These plastic containers are used to hold large-volume sterile solutions that are administered to patients through intravascular administration sets.
The recall is being conducted because the bags have the potential to leak once they have been used for compounding. The affected product was distributed worldwide, including nationwide in the United States and in Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.
Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the instructions provided by Baxter Healthcare.
The recalled product
- Product
- EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Bags
- Hazard
- Affected units
- 456,071
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)
- Product Code H938740 Lot #'s: 60049816
- 60049819
- 60051309
- 60051792
- 60051793
- 60051794
- 60053089
- 60053090
- 60053843
- 60059169
- 60061937
- 60063161
- 60066271
- 60066272
- 60068167
- 60068168
- 60069705
- 60070832
- 60073335
- 60074714
Distribution
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corporation 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.
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