Baxter Healthcare Corporation recalls
36 recalls on record · 5 rated Critical · FDA
Every recall we have on record for Baxter Healthcare Corporation, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter…
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product …
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690…
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL,…
IV sets may leak.
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated…
IV sets may leak.
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck…
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.
Welch Allyn Connex Vital Signs Monitor (CVSM):
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use…
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use…
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical…
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2…
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments…
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal…
Product was distributed in the United States without proper regulatory approval.
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b)…
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b)…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL),…
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll…
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in…
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure…
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure…
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa…
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same…
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF…
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is…
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
3,65 m Extension Set with Luer-lock Connector
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
15 Liters Drain Bag
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures.…
There is a potential for foreign matter.
Compella Therapy Air Supply Unit
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.