Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk
Baxter Healthcare is recalling 158,163 units of Exactamix Empty EVA Bags because they may leak after being used for compounding.
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 medical device used for intravascular administration that may leak, posing a risk of harm to patients even though no specific injuries are reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling 158,163 units of Exactamix Empty EVA Bags (250 mL). These plastic containers are used to hold large-volume sterile solutions for administration to patients through intravascular administration sets.
The recall was initiated 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.
Healthcare facilities and consumers should stop using the affected bags and contact Baxter Healthcare Corporation for further instructions or a return.
The recalled product
- Product
- EXACTAMIX Empty EVA Bags - 250 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 — IV Bags
- Hazard
- Affected units
- 158,163
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 (18)
- Product Code H938737 Lot #'s: 60064550
- 60070834
- 60075460
- 60083515
- 60088184
- 60089783
- 60091143
- 60097820
- 60093840
- 60096703
- 60103940
- 60110724
- 60112088
- 60116852
- 60119378
- 60119379
- 60127187
- 60128808.
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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