Baxter Recalls EXACTAMIX Empty EVA Bags Due to Potential Leaking
Baxter Healthcare is recalling 281,350 units of EXACTAMIX Empty EVA Bags because they may leak after being used for compounding.
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 medical device used for intravascular administration that may leak, posing a risk of harm to patients even though specific injuries are not reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling 281,350 units of EXACTAMIX Empty EVA Bags (3000 mL). These plastic containers are used to hold large-volume sterile solutions that are administered to patients through an intravascular administration set.
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 providers and patients should check their inventory for the specific product code H938741 and the lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- EXACTAMIX Empty EVA Bags - 3000 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
- 281,350
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 H938741 Lot #'s: 60056339
- 60066281
- 60066284
- 60066289
- 60073320
- 60099757
- 60064600
- 60078408
- 60091166
- 60094120
- 60094126
- 60099759
- 60101131
- 60101132
- 60101135
- 60101136
- 60102485
- 60103966
- 60105206
- 60105404
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.
See all 5 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- HighBaxter Head Positioning Adapter May Loosen During Patient Positioning
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · leaking
See all →- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighBD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
FDA (Devices) · 2025-06-18
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking
FDA (Devices) · 2025-05-07