Class I recall

Teleflex Incorporated Announces Worldwide Voluntary Recall of COMFORT FLO® Humidification System

Retrieved on: 
Friday, February 14, 2020
Teleflex, Health, Food and Drug Administration, Flo, Class I recall

Products manufactured after June 2019 are now being packaged with our new COMFORT FLO columns for high flow therapy.

Key Points: 
  • Products manufactured after June 2019 are now being packaged with our new COMFORT FLO columns for high flow therapy.
  • The U.S. Food and Drug Administration (FDA) has classified the recall of the COMFORT FLO Humidification System as a Class I recall.
  • Teleflex is a global provider of medical technologies designed to improve the health and quality of peoples lives.
  • Teleflex employees worldwide are united in the understanding that what we do every day makes a difference.

Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency's new steps to strengthen the process of initiating voluntary recalls

Retrieved on: 
Tuesday, April 23, 2019
Food and Drug Administration, Health, United States Public Health Service, Articles, Food law, United States administrative law, Pharmaceuticals policy, Class I recall

The FDA plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.

Key Points: 
  • The FDA plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.
  • That's why the FDA's work is also keenly focused on guiding companies on steps needed to ready their facilities and staff for possible recall situations.
  • The draft guidance provides recommendations for companies who manufacture or distribute FDA-regulated products to adopt in readying their staff for potential recall situations.
  • The FDA will also continue to refine and improve our ability to quickly communicate information to the public on recall situations.

Getinge Informs About a Voluntary Medical Device Recall for the QUADROX-i Neonatal Oxygenator

Retrieved on: 
Monday, November 26, 2018
Medical equipment, Medicine, Health, Oxygenator, Cardiopulmonary bypass, Cardiac surgery, Extracorporeal, Class I recall, Membrane oxygenator

Getinge is informing about a global voluntary Medical Device Recall for the QUADROX-i Neonatal Oxygenator.

Key Points: 
  • Getinge is informing about a global voluntary Medical Device Recall for the QUADROX-i Neonatal Oxygenator.
  • Getinge has reported to relevant competent authorities according to applicable regulations and does not expect the cost for the recall to be material.
  • The QUADROX-i Neonatal Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery for neonatal patients.
  • In the US, the recall affects 9 customers, and has been classified as a Class I recall by the FDA.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Retrieved on: 
Wednesday, September 26, 2018
Food recalls, Health, Product liability, Food safety, Food and Drug Administration, Food and drink, Product recall, Class I recall, Food Safety and Inspection Service

When a food recall is initiated, the FDA typically works with companies to publicize labeling information, product descriptions, lot numbers, as well as photographs and geographic or retail-related distribution information.

Key Points: 
  • When a food recall is initiated, the FDA typically works with companies to publicize labeling information, product descriptions, lot numbers, as well as photographs and geographic or retail-related distribution information.
  • Moreover, in most cases, information publicized by the recalling company is sufficient to allow consumers to identify and avoid recalled product.
  • That's why today the FDA issued new draft guidance that describes situations when disclosing retail information for products undergoing recalls is appropriate.
  • We believe that providing retailer information for certain recalls will also improve the efficiency of recalls by helping the public to identify and focus on the foods that are recalled.