Tag-Archive for ◊ FDA lawsuit ◊

• Thursday, November 14th, 2013

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan. The tentative plan, which must win court approval, represents one of the largest payouts for product liability […]

• Tuesday, October 22nd, 2013

Bard LifeStent Solo Vascular Stent – Failure to Deploy Stent Recall Class: Class I Date Recall Initiated: September 30, 2013 Product: LifeStent Solo Vascular Stent Product Codes/Lot Numbers To locate product codes and lot numbers of affected products, refer to FDA’s Class I Recall information under “Additional Links” below. The affected products were manufactured and […]

• Friday, October 18th, 2013

FDA regulators handed Medtronic a warning letter over issues associated with its Paradigm-branded insulin infusion pumps. This comes on top of a Class I recall this past summer over a faulty part in the infusion pump system. On September 19th, regulators alerted the company to violations found during an inspection of its production facility in Northridge, CA. […]

• Friday, October 11th, 2013

MINNEAPOLIS – Oct. 8, 2013 – The U.S. Food and Drug Administration’s (FDA) Circulatory Systems Devices Advisory Panel today voted that biventricular (BiV) pacing with Medtronic, Inc. (NYSE: MDT) devices is beneficial for treating patients who have atrioventricular (AV) block and left ventricular (LV) systolic dysfunction, compared to conventional right ventricular pacing. The panel voted […]

• Tuesday, September 24th, 2013

RTI Surgical gets some Wall Street love on announcing that a new FDA inspection confirms changes made at its Florida manufacturing facility. Florida-based RTI Surgical (NSDQ:RTIX) announced this week that a new inspection of its manufacturing facility confirmed that the company had taken the appropriate actions to correct issues cited in an FDA warning letter issued last year. […]

• Tuesday, September 24th, 2013

Medtronic asks a federal judge in Arizona to reconsider a ruling that kept a lawsuit over its Infuse bone-growth protein alive. Medtronic (NYSE:MDT) wants a federal judge in Arizona to reconsider his decision not to dismiss a lawsuit filed over its Infuse bone-growth protein. Fridley, Minn.-based Medtronic had asked Judge G. Murray Snow of the […]

• Monday, September 23rd, 2013

Baxter Initiates Voluntary Recall of Two Lots of Dual Luer Lock Caps  September 19, 2013 – Baxter International Inc. announced today it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. […]

• Monday, September 09th, 2013

(Reuters) – Germany’s Siemens recalled 78,020 microbiology testing panels in the United States as they are reporting false results, U.S. health regulators said. The defect found in certain MicroScan panels may lead to treatment of patients with inappropriate antibiotics or to a delay in the therapy they need, the U.S. Food and Drug Administration said […]

• Wednesday, September 04th, 2013

A management shakeup isn’t the only issue facing Raleigh diagnostics firm LipoScience (Nasdaq: LPDX), which once again finds itself at odds with the Food and Drug Administration. The newly public company is voluntarily withdrawing its application to market a new blood test, but isn’t giving up on the product. Specifically, LipoScience is withdrawing its 510 […]

• Friday, August 23rd, 2013

WASHINGTON, Aug. 20 (UPI) — Covidien, a healthcare products producer, initiated a voluntary recall of certain lots of Monoject prefill flush syringes, U.S. government officials say. The U.S. Food and Drug Administration says the recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave […]