Important FDA Notices

​The U.S. Food and Drug Administration (FDA) was recently notified that three letters were sent to Smiths Medical customers with corrected use instructions for certain CADD-Solis Ambulatory Infusion Pumps and CADD-Solis VIP Ambulatory Infusion Pumps. Corrections impact the Infusion Pump False Occlusion Alarm, Infusion Pump Thermal Damage Issue, and Infusion Pump Intermittent Connection Issue. 

These recalls​, identified as the most serious type, involve updating instructions for using the devices. They do not involve removing them from where they are used or sold. These devices may cause serious injury or death if you continue to use them without following the updated instructions.  

Potential health consequences of these issues include interruptions or delays of therapy, which can lead to serious patient injury or death depending on the clinical situation and the type of medication being administered. Smiths Medical has not reported any serious injuries or deaths associated with these issues. 

Health care professionals may report adverse reactions or quality problems they experience using these devices to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

Medication Recall from Amneal Pharmaceutical LLC 

The FDA also posted a recall notice for Amneal Pharmaceutical LLC Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only. The company is recalling three lots of these tablets, distributed nationwide to wholesalers/distributors between December 4, 2024, and May 15, 2025, as they may exhibit black spots on the tablet surface due to microbial contamination. 

For Medical Inquiries or to report Adverse Events or quality problems, please contact Amneal Drug Safety by phone at 1-877-835-5472 or email. Health care professionals and patients are also encouraged to report adverse events or side effects related to the use of these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  

 

Reach out to the AHCA/NCAL Regulatory team​ with additional questions.​​