Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Improperly performed testing prior to release
Read the official notice →- Date
- 2024-08-14
- Country
- United States
- Brand
- Baxter Healthcare
- Product
- Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
- Classification
- Class II
- Units
- US Nationwide distribution in the state of Florida.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-09-25
USBaxter 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.
- 2024-08-28
- US
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…
- 2024-08-14
- 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 → - 2024-07-17
- US
Baxter Healthcare Corporation recalls Braun Thermoscan¿ PRO 6000 Ear Thermometer
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
FDA · DeviceBaxter Healthcare CorporationDistributed to United States, Canada, Australia, Malaysia, New Zealand,…Official notice →
Other drugs & medical recalls in the United States
- 2024-08-14
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for…
Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Luminex Corporation recalls Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
FDA · DeviceLuminex CorporationUS Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA,…Official notice → - US
Artivion, Inc recalls (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared…
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
FDA · DeviceArtivion, IncUS Nationwide distribution in the states of CA, DC, FL, and NY.Official notice → - US
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
FDA · DeviceLEICA BIOSYSTEMS NUSSLOCH GMBHUS Nationwide, including government distribution.Official notice → - US
Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model…
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
- US
American Contract Systems, Inc. recalls American Contract Systems Spine Pack convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.Official notice →