Baxter Recalls EXACTAMIX Empty EVA TPN Bags Due to Leak Risk
Baxter Healthcare is recalling EXACTAMIX Empty EVA TPN 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 FDA classified this as a Class II recall for a medical device with a potential leak hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Baxter Healthcare Corporation is recalling EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bags. The recall involves 11,389,800 units of the product in five sizes: 250mL, 500mL, 1000mL, 2000mL, and 3000mL. These empty bags are used by pharmacists and pharmacy technicians in pharmacies and compounding centers to compound large-volume sterile solutions for administration to a single patient.
The recall was initiated because the bags have the potential to leak once used for compounding. The FDA has classified this recall as Class II, which indicates that use of, or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected products were distributed worldwide, including nationwide in the United States and in countries such as Canada, Australia, New Zealand, Singapore, Korea, Taiwan, Thailand, Hong Kong, Brazil, Colombia, Mexico, Chile, Uruguay, the Dominican Republic, and Panama. Specific lot numbers and expiration dates are listed in the official recall notice. Users of these products should stop using the affected bags and contact Baxter Healthcare or their local FDA office for further instructions.
The recalled product
- Product
- EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — IV/TPN Bags
- Hazard
- Affected units
- 11,389,800
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)
- 1. UDI Number: 00085412477213
- Lot Numbers (60060391
- 60061809
- 60061816
- 60061819
- 60063137
- 60063138
- 60063141
- 60063142
- 60063143
- 60063146
- 60063147
- 60063148
- 60064545
- 60064546
- 60064547
- 60064548
- 60064549
- 60064551
- 60064552
Distribution
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