Baxter Healthcare Corporation recalls Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion…
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ…
Read the official notice →- Date
- 2024-08-28
- Country
- United States
- Brand
- Baxter Healthcare
- Product
- Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and…
- Classification
- Class II
- Units
- US, Nationwide
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Baxter Healthcare recalls
- 2024-10-30
US
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3)…
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
- 2024-09-25
US
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
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…
- 2024-09-11
US
Baxter Healthcare Corporation recalls Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose…
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- 2024-08-14
US
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Improperly performed testing prior to release
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Florida.Official notice →US
Baxter Healthcare Corporation recalls Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice →- 2024-07-24
US
Baxter Healthcare Corporation recalls Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent…
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
FDA · DeviceBaxter Healthcare CorporationNationwide distribution. International distribution to Canada, France, and…Official notice →
Other drugs & medical recalls in the United States
- 2024-08-28
US
Microtek Medical Inc. recalls Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
FDA · DeviceMicrotek Medical Inc.Distributed nationwide and internationally to Canada, Mexico, New Zealand,…Official notice →US
Covidien recalls McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →US
Inari Medical - Oak Canyon recalls ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System,…
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter…
FDA · DeviceInari Medical - Oak CanyonWorldwide - US Nationwide distribution including in the states of PA, FL, GA,…Official notice →US
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx…
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
US
Aurobindo Pharma USA Inc recalls Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by:…
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
US
Zeco LLC recalls Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold…
CGMP Deviations: sterile water not used for production
FDA · DrugZeco LLCNationwide within the United States and Toronto, Canada (Rubbing alcohol)Official notice →