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Health IT Articles Posted and Curated by Health eServices

Update: Recommendations for Certain O&M Halyard Surgical...

29 September 2023
Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations.

SCYNEXIS Issues a Voluntary Nationwide Recall of...

28 September 2023
SCYNEXIS, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a nonantibacterial
ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tab

VistaPharm LLC Issues Voluntary Nationwide Recall of...

22 September 2023
September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product.

Universal Meditech Inc. Expands Nationwide Recall to All...

22 September 2023
Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: i. The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of these distributed

Medline Industries Recalls Hudson RCI Addipak Unit Dose...

20 September 2023
Medline Industries recalled Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, which is used for inhalation and irrigation therapy. The saline solution was found to be non-sterile.

Church & Dwight Issues Voluntary Nationwide Recall of...

14 September 2023
FOR IMMEDIATE RELEASE – September 13, 2023 – EWING, N.J – Church & Dwight Co., Inc. (NYSE:CHD) today initiated a voluntary recall of one specific lot of TheraBreath Strawberry Splash for Kids 16oz after the Company identified a microbial contamination due to the presence of yeast (Candida Parapsilo

Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode

13 September 2023
The Abbott Proclaim and Infinity neurostimulation systems deliver low-intensity electrical impulses to nerve structures. The device may be unable to exit MRI mode and resume therapy.

Bone Matrix Product: FDA Safety Communication - Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks

12 September 2023
FDA is working closely with the CDC to investigate recent reports of a TB outbreak caused by Mycobacterium tuberculosis (Mtb) that appears to be linked to a bone matrix product.

Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly

12 September 2023
The One-Way Valve, 22F x 22M is a single-use device accessory used to prevent backward flow of nitric oxide gas into the airways.

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

11 September 2023
Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune for