This week, the FDA labeled Draeger’s recall of some ventilators as Class I, the most serious kind. Draeger issued a voluntary correction, not a product removal, of specific Carina sub-acute care ventilators. The company said clinicians may continue to use the devices with adult patients and are instructed not to use the devices with pediatric […]
Draeger Medical
Recall of Draeger emergency ventilators is Class I
The FDA labeled a recall of the Draeger Medical Oxylog 3000 plus emergency and transport ventilator Class I, the most serious kind. Draeger designed its Oxylog 3000 ventilator for people who require full or partial breathing assistance from a mechanical ventilator. Healthcare professionals use it during patient transport, either in an ambulance or aircraft. They […]
Draeger has a serious ventilator filter recall
The FDA today issued a notice confirming that a recall of ventilator filters from Draeger is Class I, the most serious kind. Draeger’s SafeStar 55 breathing system filter (model number MP01790), distributed between Aug. 18, 2021, and Oct. 12, 2021, is the affected product. The company initiated the recall on May 9, 2022, and has […]
Dräger boosts N95 mask production with new U.S. facility opening
Dräger announced today that it is opening a new production facility in Pennsylvania to manufacture N95 respirator masks. Telford, Pa.-based Dräger’s new production facility is located in Montgomeryville, Pa., and is set to begin production in September 2020 with 50 highly skilled jobs slated to be added to the local community. Get the full story […]
FDA grants emergency nod to ventilators from Medtronic, other companies
The FDA has granted four companies’ ventilators emergency use authorization this week to treat COVID-19 patients, as well as a fifth company’s anesthesia gas machine for use as a ventilator. Gaining the latest EUAs were machines by Medtronic (NYSE:MDT), Draeger, MEK-ICS, Ventec Life Systems, and startup CoLabs. One of those EUAs went to Medtronic’s Puritan Bennett […]
U.S. ventilator manufacturing is rapidly expanding: Here’s how
Amid a shortage of life-saving ventilators due to the coronavirus pandemic, medical device companies are rapidly expanding production, trade group AdvaMed reported today. Respiratory device companies that belong to AdvaMed have boosted ventilators production to 2,000–3,000 per week — and expect to soon reach 5,000–7,000 ventilators per week. Last year, the same companies were making […]
Dräger Medical cited in FDA warning letter
This article has been updated with comments from Dräger Medical. The FDA has issued a warning letter to Dräger Medical following an inspection of its Andover, Mass., facility in August and September 2019. The agency faulted the patient-monitoring company for failing to file for 510(k) clearance of its Infinity acute care system (IACS) M540 although it made […]
Draeger lands $10m anesthesia contract with DoD
The U.S. Defense Dept. recently announced that Draeger has won a nearly $10 million contract for anesthesia recording and monitoring device sustainment services. The July 26 announcement of the five-year, firm-fixed-price contract came days after DoD also awarded a $60 million contract to Draeger for patient monitoring systems, subsystems, accessories, consumables and training. The latest contract […]
Hamilton Medical, Draeger win DoD deals
The U.S. Defense Dept. said yesterday that Hamilton Medical and Draeger won Pentagon contracts worth $75 million and $60 million, respectively. Hamilton Medical won a contract with the agency for patient monitoring and capital equipment systems and accessories, the DoD said. The company topped 36 other companies for the contract. The five-year base contract with […]
FDA issues select recall of Draeger Jaundice Meters
The FDA recently posted notice of a select recall of Draeger Medical Jaundice Meters over issues with users misinterpreting the display. The recall affects all Draeger Medical’s Jaundice Meter JM-105 units, and has been labeled as a Class I recall, indicating the potential for serious injury or death. The Draeger Jaundice Meter is designed for […]
Zimmer Biomet picks ex-Covidien exec Lannum for IR chief | Personnel Moves – March 20, 2018
Zimmer Biomet (NYSE:ZBH) said yesterday it tapped former Covidien investor relations head Coleman Lannum as its investor relations senior VP, reporting directly to prez & CEO Bryan Hanson. Lannum has more than 15 years in investor relations, having held positions with Mallinckrodt Pharmaceuticals (NYSE:MNK), Covidien and Tyco Healthcare. During his time with Covidien, Lannum oversaw the company’s initial […]
