Baxter Healthcare Corporation recalls Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and…
Firm discovered a firmware memory leak with a supplier-manufactured component.
Read the official notice →- Date
- 2022-05-25
- Country
- United States
- Brand
- Baxter Healthcare
- Product
- Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and…
- Classification
- Class II
- Units
- US Distribution to states of: NC and VA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-07-06
USBaxter Healthcare Corporation recalls #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Packaging error.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Japan, Canada,…Official notice →- 2022-06-08
- US
Baxter Healthcare Corporation recalls 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.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.Official notice → - US
Baxter Healthcare Corporation recalls In-Line ventilator adaptor
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL,…Official notice → - 2022-05-11
- US
Baxter Healthcare Corporation recalls Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to…
There is a potential for foreign matter.
FDA · DeviceBaxter Healthcare CorporationDistribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS…Official notice → - 2022-05-04
- US
Baxter Healthcare Corporation recalls PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Mexico, Brazil,…Official notice → - 2022-04-27
- US
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Product is mislabeled as self-righting Luer slip tip caps, yellow.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of FL, GA,…Official notice →
Other drugs & medical recalls in the United States
- 2022-05-25
- US
Randox Laboratories Ltd. recalls CK MB Calibrator, Catalogue Number CK2393
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.
FDA · DeviceRandox Laboratories Ltd.Domestic distribution to WV and PR. International distribution to Bangladesh,…Official notice → - US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ,…Official notice → - US
Abbott Vascular recalls Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
There is a potential that the proximal marker may separate from the imaging catheter
FDA · DeviceAbbott VascularUS:AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD ME MI MN MO MT NC NE NH…Official notice → - US
Luminex Corporation recalls Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
FDA · DeviceLuminex CorporationUS:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: NoneOfficial notice → - US
Neuralynx Inc recalls ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United…
Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by…
FDA · DeviceNeuralynx IncU.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.Official notice → - US
Total Resources Intl recalls Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories…
ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that were later placed into Total Resources Intl kits. Acetaminophen and electrolyte tablets were recalled due to a Fluid Bed Drier exhaust system…
FDA · DeviceTotal Resources IntlUS: IL, PA, VA, AR, TX, IA, DE, GA, NY, LA, AL, IN, MI, MO, NC, KS, CO, AZ,…Official notice →