5 results
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40ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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OxyMask O2 Adult REF OM-1125-14
FDA Recall
Open, Classified
·Southmedic, Inc.·Product code CCK·May 25, 2021
Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934
FDA Recall
Open, Classified
·Signature Orthopaedics Europe Ltd Unit A, IDA Business & Technology Park Garrycastle Athlone Ireland·Product code MEH·October 9, 2019
iLet Bionic Pancreas, REF: BB1001
FDA Recall
Open, Classified
·Beta Bionics, Inc.·Product code QFG·September 23, 2025
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
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code ONB·November 6, 2024