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Arrow International

The worst catheter-based device recalls of 2020

February 19, 2021 By Danielle Kirsh

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 […]

Filed Under: Catheters, Featured, Food & Drug Administration (FDA), Recalls Tagged With: Abbott Vascular, Applied Medical, Arrow International, Boston Scientific, Cook Medical, Endologix, LeMaitre Vascular, Medtronic, Teleflex, Vascular Solutions

FDA updates on Teleflex’s Class I Arrow intra-aortic balloon recall

March 17, 2016 By Fink Densford

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 […]

Filed Under: Cardiovascular, Catheters, Recalls Tagged With: Arrow International, Teleflex

Teleflex’s Arrow division outsources to Mexico

May 30, 2014 By Arezu Sarvestani

Teleflex's Arrow division outsources to Mexico

UPDATED June 2, 2014, with comment from Teleflex.

Technology giant Teleflex (NYSE:TFX) informed the city of Asheboro, N.C., this week that it plans to close down a manufacturing facility, resulting in layoffs for most of the plant’s 635 workers.

Filed Under: News Well, Outsourcing Tagged With: Arrow International, Job creation, Layoffs, Teleflex

GPOs: Novation and Premier tout new deals

October 18, 2011 By MassDevice staff Leave a Comment

Novation
Premier

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.

Filed Under: Catheters, News Well, Patient Monitoring Tagged With: Arrow International, Deals Roundup, Novation, OSI Systems Inc., Premier Inc., Spacelabs Healthcare, Teleflex

Recalls: One down for Teleflex, one up for Masimo

August 8, 2011 By MassDevice staff Leave a Comment

Masimo
Teleflex

Masimo Corp. (NDSQ:MASI)  notched a win by reversing a voluntary recall of its noninvasive finger sensors while Teleflex Inc. (NYSE:TFX) subsidiary Arrow International continues to butt heads with the FDA.

Filed Under: Catheters, News Well, Recalls Tagged With: Arrow International, Masimo, Teleflex

Arrow is in good FDA standing, says Teleflex

June 20, 2011 By MassDevice staff Leave a Comment

Teleflex
FDA

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Arrow International, Teleflex

Exactech rep slips prison in kickbacks scheme | Legal Roundup

March 21, 2011 By MassDevice staff Leave a Comment

MassDevice.com 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.

Filed Under: Legal News, News Well, Patent Infringement, Product Liability Tagged With: Accuray Inc., Argentum Medical, Arrow International, Codman & Shurtleff, Exactech Inc., Given Imaging, IntroMedic, Johnson and Johnson, Noble Biomaterials, OrbusNeich

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