Recall Z-0167-2020— Baxter Healthcare Corporation
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2019-09-18, terminated 2021-02-16. It names one FDA 510(k) clearance: K900585. 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 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.. Reason: Potential ability to leak once used for compounding..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-18
- Terminated
- 2021-02-16
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Potential ability to leak once used for compounding.
Data sourced from openFDA. This site is unofficial and independent of the FDA.