Fresenius Medical Care Holdings, Inc. - 2008 Series Hemodialysis Machines - Class 1 Recall
2008T HD SYS. CDX BLUESTAR (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 7, 2023 Category: Medical Devices Source Type: alerts

Fresenius Medical Care Holdings, Inc. - 2008 Series Hemodialysis Machines - Class 1 Recall
2008T Hemodialysis SYS, with CDX (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 7, 2023 Category: Medical Devices Source Type: alerts

AQUACETIC-30 (cleaning solution for hemodialysis machines) solution, concentrate [AQUA MEDICA, S.A. DE C.V.]
Updated Date: Wed, 30 Aug 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 30, 2023 Category: Drugs & Pharmacology Source Type: alerts

CITRACID-50 (desinfectant solution for hemodialysis machine) solution, concentrate [AQUA MEDICA, S.A. DE C.V.]
Updated Date: Wed, 30 Aug 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 30, 2023 Category: Drugs & Pharmacology Source Type: alerts

DRY-CID (dry concentrate for hemodialysis) powder, for solution [AQUA MEDICA, S.A. DE C.V.]
Updated Date: Tue, 29 Aug 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 29, 2023 Category: Drugs & Pharmacology Source Type: alerts

MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts

MEDLINE INDUSTRIES, LP - Northfield - Custom Sterile and NonSterile Procedural Kits containing Turkuaz Ultrasound Gel - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Number: DYNJ47215D; d. CENTRAL LINE TRAY, Model Number: DYNJ42902B; e. CENTRAL LINE UNIVERSAL INSERTION, Model Number: CVI3780; f. CLOSURE PACK, Model Number: DYNJ83054A; g. DBD-PICC LINEPACK PCLUI642-LF, Model Number: DYNJ47717A; h. ER CENTRAL LINE KIT, Model Number: P155508B, P155508C; i. HEMODIALYSIS CENTRAL LINE, Model Number: DYNJ63347; ...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts

Outset Medical, Inc. - Tablo Hemodialysis System - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 8, 2023 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Revaclear - Class 2 Recall
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Revaclear - Class 2 Recall
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Revaclear - Class 2 Recall
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Revaclear - Class 2 Recall
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Revaclear - Class 2 Recall
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 23, 2022 Category: Medical Devices Source Type: alerts

Fresenius Medical Care Holdings, Inc. - Class 2 Recall
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2022 Category: Medical Devices Source Type: alerts

QUABIC-100 (hemodialysis grade sodium bicarbonate solution) solution, concentrate [AQUA MEDICA, S.A. DE C.V.]
Updated Date: Wed, 30 Nov 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 30, 2022 Category: Drugs & Pharmacology Source Type: alerts