The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019. The list of the most serious catheter-based device recalls […]
Arrow International
FDA updates on Teleflex’s Class I Arrow intra-aortic balloon recall
The FDA today labeled Teleflex‘s (NYSE:TFX) recall of Arrow intra-aortic balloon cath and percutaneous insertion kits as a Class I recall. Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The devices are being […]
Teleflex’s Arrow division outsources to Mexico
GPOs: Novation and Premier tout new deals
Hospital group purchasing organizations Novation and Premier signed new contracts this week, covering patient monitoring solutions, intra-aortic balloon catheters and pumps.
Novation awarded a three-year contract to Spacelabs Healthcare, a subsidiary of OSI Systems Inc. (NSDQ:OSIS), for patient monitoring and connectivity solutions.
Recalls: One down for Teleflex, one up for Masimo
Arrow is in good FDA standing, says Teleflex
Teleflex Inc. (NYSE:TFX) announced that it successfully resolved all outstanding issues cited in a FDA Warning Letter regarding quality systems control issues at its subsidiary Arrow International.
The Warning Letter was sent in October 2007, just weeks after Limerick, Pa.-based Teleflex completed its acquisition of Arrow.
Exactech rep slips prison in kickbacks scheme | Legal Roundup
A former sales rep for Exactech Inc. avoided prison but landed five years’ probation and $56,000 in fines after pleading guilty to setting up a kickbacks scheme to encourage orthopedic surgeons to use the company’s hip and knee implants.
Judge Garrett Brown of the U.S. District Court for New Jersey handed down the sentence to Douglas Donofrio, the former New York-area sales director for the Gainesville, Fla.-based company. Donofrio pleaded guilty to running the scheme between 2002 and 2008.
