Baxter Healthcare Corp
Baxter Healthcare Corp holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2019, with 86 FDA device recalls on record.
Top product codes for Baxter Healthcare Corp
FDA recalls by Baxter Healthcare Corp
10 most recent of 86- Z-3133-2017 — Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
- Z-0370-2017 — GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
- Z-0670-2017 — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
- Z-0671-2017 — Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
- Z-0672-2017 — V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.
- Z-2533-2016 — Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.
- Z-2049-2016 — PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
- Z-1839-2016 — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Z-1838-2016 — COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Z-1840-2016 — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Baxter Healthcare Corp
1–100 of 505- K190910 — PrisMax System Version 2
- K163530 — PrisMax Control Unit
- K130531 — ULTRAFUSE
- K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
- K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
- K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S
- K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
- K121092 — FLOWEASE [SUBCUTANEOUS] INFUSION SET
- K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
- K111217 — ADDITIVE CAP
- K102936 — HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
- K103551 — INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
- K103245 — CELSTAT
- K101385 — DUAL LUER LOCK CAP, MODEL 2C6250
- K090002 — ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
- K081717 — TRICOS A RESORBABLE BONE SUBSTITUTE
- K081721 — TRICOS A RESORBABLE SUBSTITUTE
- K081289 — V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
- K072576 — CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED
- K071222 — INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
- K070125 — COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
- K052973 — IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K
- K061515 — RENALSOFT
- K060074 — INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326
- K053512 — HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
- K051722 — TRICOS T
- K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
- K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
- K040985 — PUMP CONNECTIVITY INTERFACE
- K042936 — SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
- K042410 — BAXJECT II
- K041428 — ACCUSOL DIALYSIS SOLUTION
- K041191 — COLLEAGUE VOLUMETRIC INFUSION PUMPS
- K031676 — HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
- K031882 — ENDOSCOPIC APPLICATOR
- K031566 — SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
- K030099 — BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
- K030974 — EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
- K030975 — EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
- K023664 — SYNTRA + DIALYZER, MODEL 200
- K013562 — AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE
- K021615 — BAXTER ACCURA SYSTEM, MODEL 5M5660
- K020666 — DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
- K014088 — DUPLOREACH
- K021274 — PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
- K020485 — ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
- K012988 — HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
- K011317 — MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM
- K010566 — COLLEAGUE VOLUMETRIC INFUSION PUMP
- K003747 — C1-INHIBITOR MICROTITER ASSAY DEVICE
- K002210 — SYNTRA DIALYZER, MODEL SYNTRA 120, 160
- K003730 — CHEMO-AIDE DISPENSING PIN
- K003616 — COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
- K003245 — HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
- K001685 — PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
- K003193 — DUPLOGRIP
- K003225 — SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
- K000664 — VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
- K002679 — 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351
- K002739 — INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
- K002380 — INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
- K002211 — COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
- K001063 — SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
- K981089 — TISSOMAT AND SPRAY SET
- K992532 — VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
- K001422 — PSN HEMODIALYZER, MODELS PSN 170, PSN 210
- K000657 — LUER ACCESS UNIVERSAL VIAL ADAPTER
- K992894 — MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
- K993120 — MODIFIED BLOOD RECIPIENT SET
- K993387 — IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
- K984590 — 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- K984060 — LUER ACCESS INJECTION SITE
- K990953 — RENAL LINK
- K984381 — BURETROL SOLUTION SETS
- K983294 — ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
- K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
- K982102 — SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
- K982672 — COLLEAGUE PUMP SYRINGE ADAPTER SET
- K981792 — SOLUTION ADMINISTRATION SET
- K974652 — BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
- K974571 — SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
- K980656 — PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
- K980658 — PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
- K981318 — DUAL LUER LOCK CAP
- K970653 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K970662 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
- K974397 — STERILE SALINE FOR CATHETER CARE
- K974155 — BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT
- K970663 — CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
- K963933 — PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
- K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
- K973654 — VIAL-MATE RECONSTITUTION DEVICE (2B8071)
- K961008 — AUTOMIX 3+3/AS COMPOUNDER SYSTEM
- K972579 — HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
- K970591 — BLOOD MONITOR PUMP
- K972159 — FENWAL 40 MICRON TRANSFUSION FILTER
- K971168 — ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
- K971701 — CONTINU-FLO SOLUTION SET
- K955622 — AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.