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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

Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication

February 9th, 2022|

The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA.

Lidocaine HCl Topical Solution 4% Due to Super Potency

October 14th, 2021|

Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling five lots of Lidocaine HCl Topical Solution 4% because the firm's testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint. Use of the super potent product would result in a higher than intended lidocaine

Potential for Medication Overdose with ENFit Low Dose Tip Syringes

October 14th, 2021|

The U.S. Food and Drug Administration (FDA) is informing patients and healthcare providers about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes. The FDA is aware of the potential for overdose if the user does not clear the moat area around the tip of the ENFit

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

October 5th, 2021|

Medtronic updated this recall with information that Medtronic will replace any MiniMed™ 600 series insulin pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty

FDA Issues Revised Policy on Face Masks and Respirators During COVID-19

September 20th, 2021|

The U.S. Food and Drug Administration (FDA) issued revised guidance to help expand the availability of face masks, barrier face coverings, and face shields for the general public, including healthcare personnel, and surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for healthcare personnel for the duration of the COVID-19 public health emergency: Enforcement Policy for Face Masks,