Aspiration Catheter Recall

Q’Apel Medical, Inc. is recalling Hippo 072 Aspiration Systems and the Cheetah Delivery Tool after receiving an FDA warning letter that raised concerns about internal processes and the scope of clearance for the Hippo product, as it relates to the distal tip. Specifically, the FDA has raised questions about the features and characteristics of the distal tip of the aspiration catheter when removing a clot during aspiration.

At this time, Q’Apel Medical, Inc. has reported two injuries related to this issue. There have been no reports of death.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with questions about this recall should contact Q’Apel Medical, Inc. customer service at orders@qapelmedical.com or 510-738-6255.

Convenience Kit Recall

Medline Industries, LP, is recalling neonatal and pediatric convenience kits that contain recalled Smiths Medical ORAL/NASAL Endotracheal Tubes. The recalled tubes may have a smaller diameter than expected, which may prevent the patient from receiving proper ventilation. The use of these affected products may cause serious adverse health consequences, including lack of oxygen (hypoxia) that may lead to organ failure, swelling of the larynx (laryngeal edema), cardiopulmonary arrest, and death.

At this time, Medline Industries, LP, has reported eight injuries related to this issue. There have been no reports of death.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with questions about this recall should contact 866-359-1704 or email Recalls@Medline.com.

Blood Products Administration Set Recall

The U.S. Food and Drug Administration (FDA) is aware that Fresenius Kabi has identified a specific lot of the Ivenix LVP Blood Products Administration Set that was incorrectly assembled.

Clinical outcomes can vary from asymptomatic to serious adverse events, especially in vulnerable populations such as neonates, critically ill patients, or those undergoing large-volume transfusions. Short-term and long-term complications will vary depending on the patient population, the underlying condition, health status of the patient, and the treatment regimen.

At this time, Fresenius Kabi has not reported serious injuries or deaths associated with this issue.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi at Ivenix_support@fresenius-kabi.com or 855-354-6387.