Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the Recalled by Baxter Healthcare Corporation Due to Potential ability to leak once used for compounding.

Date: September 18, 2019
Company: Baxter Healthcare Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.

Affected Products

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 destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.

Quantity: 11,389,800 units total

Why Was This Recalled?

Potential ability to leak once used for compounding.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Baxter Healthcare Corporation

Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report