Recall

Class I Recall on Stryker Spine Device

Posted September 12, 2013 in Drug and Medical Device Lawsuits | Product News and Recalls | Recall

The Food and Drug Administration has issued a Class 1 Recall on Stryker Spine – OASYS Midline Occiput Plates due to reports of fracture of the pin that connects the implant’s tulip head to the plate body. This may cause serious adverse health consequences including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.

According to a FDA release, the OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System used ...

Categories: Drug and Medical Device Lawsuits, Product News and Recalls, Recall

FDA Announces Voluntary Recall of Nova Max Blood Glucose Test Strips

Posted August 12, 2013 in Product News and Recalls | Recall

Last week, the U.S. Food and Drug Administration announced a voluntary recall of Nova Max Blood Glucose Test Strips that may report a false, abnormally high blood glucose result.

The FDA stated in a news release that “under certain conditions, a false, abnormally high blood glucose level could result in an insulin dosing error, requiring the user to seek immediate medical attention.”

It has been reported that nearly 62 million strips may be affected by this recall. ...

Categories: Product News and Recalls, Recall

Tags: diabetes, FDA, nova max

Nationwide Recall of Aspirin Bottles Containing Tylenol

Posted July 16, 2013 in Product News and Recalls | Recall

A nationwide emergency recall of baby aspirin bottles was initiated on June 17th, 2013 after a CVS pharmacist discovered one bottle had been filled with acetaminophen — otherwise known by the brand name Tylenol.

More than 16,000 bottles have voluntarily been recalled by Advance Pharmaceutical, Inc., the company responsible for the filling and labeling of the bottles. These bottles are labeled “Enteric Coated Aspirin Tablets, 81-mg.” The recall was prompted by a ...

Categories: Product News and Recalls, Recall

Tags: advance pharmaceutical, aspirin, Recall, tylenol

Medical device regulations criticized

A story in Canadian news magazine MacLean’s deals with the haphazard nature of medical device regulation, characterizing the problem as a “scandal in the making.”

According to the article, flawed oversight of medical devices – essentially any medical product that doesn’t work through a chemical process – is an international problem that exists in the United States and Europe, as well as Canada.

The article specifically mentions two medical devices that serve ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Health, Legal Issues, Product Liability, Product News and Recalls, Recall, Transvaginal Mesh Lawsuit

Tags: debris, DePuy, early failure, hip implants, Johnson & Johnson, lawsuits, metal-on-metal, transvaginal mesh

Closed Fresenius dialysis center had history of problems

Posted June 19, 2013 in Granuflo Recall Lawsuit | Health | Product Liability | Product News and Recalls | Recall

A dialysis center that was shut down in Bessemer, Alabama, following the infection-related deaths of two patients has a prior history of health violations, according to a report on Al.com.

In a report about a year ago, the Alabama health department cited the clinic over multiple infection-control deficiencies. In one of those cases, a patient was hospitalized.

The clinic’s owner, German company Fresenius, has previously been accused of subjecting patients to continue reading...

Categories: Granuflo Recall Lawsuit, Health, Product Liability, Product News and Recalls, Recall

Tags: cardiac arrest, Food and Drug Administration, Fresenius Medical Care, Fresnius, GranuFlo, heart, kidney dialysis

Lawyers worried about regulatory change for hip implants

The leading plaintiff trial lawyers association has expressed concerns to the U.S. Food and Drug Administration that a proposed regulatory change might prevent people injured by faulty all-metal hip implants from suing the manufacturers for damages.

The implants in question, such as those manufactured by Johnson & Johnson’s DePuy Orthopaedics subsidiary, have both a ball and a socket coated in a ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Health, Product Liability, Product News and Recalls, Recall

Tags: debris, DePuy, early failure, hip implants, Johnson & Johnson, lawsuits, metal-on-metal

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Recall

Class I Recall on Stryker Spine Device

FDA Announces Voluntary Recall of Nova Max Blood Glucose Test Strips

Nationwide Recall of Aspirin Bottles Containing Tylenol

Medical device regulations criticized

Closed Fresenius dialysis center had history of problems

Lawyers worried about regulatory change for hip implants

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