Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue

August 30th, 2022|

The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and healthcare providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain

Class 1 Recall: Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA

August 10th, 2022|

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.  Device Use Haimen Shengbang Laboratory Equipment Co. Ltd.’s Viral Transport Media Container is a sampling swab and a tube containing viral sampling medium (the liquid that maintains a specimen

Revised Emergency Use Authorization (EUA) for Paxlovid

July 11th, 2022|

The U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Read More

Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care

May 9th, 2022|

The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still be

Baxter Class 1 Recall

March 18th, 2022|

Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events. After an upstream occlusion alarm, failure to fully resolve any upstream occlusion before restarting the infusion can

Sodium Acetate Injection-USP by Fresenius Kabi

March 5th, 2022|

Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials. Microscopic and elemental analyses determined the presence of particulates composed of