8 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
FDA Recall
Open, Classified
·MRP, LLC dba Aquabiliti·Product code NGT·December 28, 2023
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
FDA Recall
Open, Classified
·TANGENT ENDOSCOPY, LLC·Product code FBN·March 23, 2026
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
FDA Recall
Open, Classified
·Outset Medical, Inc.·Product code FIP·January 24, 2023
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 21, 2022
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 16, 2022
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·May 16, 2024
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 16, 2022
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·June 21, 2022