Home Correction letter Getinge Notifies FDA Letter to Healthcare Providers Regarding Intra-Aortic Balloon Pumps

Getinge Notifies FDA Letter to Healthcare Providers Regarding Intra-Aortic Balloon Pumps

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United States Food and Drug Administration (FDA) today issued an updated reminder to healthcare providers regarding previously disclosed notifications related to field corrections to intra-aortic balloon pumps.

The updated recall is for AC powered devices with a single battery, unexpectedly short battery life, and fluid ingress. Customers have been pre-notified in accordance with the regular field remediation process and updated recall information can be found on the FDA website.

The FDA communication was released today to remind healthcare providers to ensure proper use of devices and patient health and safety. There is no material charge for Getingé associated with notifications.

Media contact:

Anna Appelqvist, Vice President of Corporate Communications
Telephone: +46 (0) 10 335 5906
E-mail: [email protected]

On Getingé

With the firm belief that every person and community should have access to the best possible care, Getingé provides hospitals and life science institutions with products and solutions to improve clinical outcomes and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating theaters, sterile reprocessing and life sciences. Getingé employs more than 10,000 people worldwide and products are sold in more than 135 countries.

https://news.cision.com/getinge/r/getinge-informs-about-fda-letter-to-healthcare-providers-related-to-intra-aortic-balloon-pumps,c3477753

https://mb.cision.com/Main/942/3477753/1514092.pdf

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