12 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·July 14, 2022
Baxter Exactamix Pro 1200, REF EXM12DY
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·December 22, 2023
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·August 20, 2024
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·August 20, 2024
Baxter Exactamix Pro 2400, REF EXM24DY
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·December 22, 2023
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·August 20, 2024
Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 20mm Admixture Device for the device to meet its intended purpose. Component: No
FDA Recall
Open, Classified
·West Pharmaceutical Services AZ, Inc.·Product code LHI·September 24, 2024
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Connector, Sterile; d. Part number 57-402, Female Slip - Female Lock Guarded Luer Connector, Sterile; and e. Part number 57-403, Female Slip - Female Slip Guarded Luer Connector.
FDA Recall
Open, Classified
·International Medical Industries, Inc.·Product code LHI·September 16, 2022
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code LHI·August 20, 2024
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.
FDA Recall
Open, Classified
·Omnicell, Inc.·Product code LHI·February 20, 2025
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code JJX·April 24, 2025
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, INc.·Product code CHI·September 12, 2023