Medical Product Archive

Pritzker | Olsen, P.A. is currently representing people injured by defective medical products and families of people whose deaths have been associated with defective products. Our experience includes litigating pharmaceutical cases, medical device cases, and a recent case involving a medication that was compounded by a pharmacy into a form that was 8 times the stated dosage.

Recalls of Unsafe Medical Devices and Prescription Medications (Drugs)
Below is a list of some products that manufacturers have recalled or modified due to defect, improper notification of risk, and/or post-marketing reports of injury and death. Most of these medications and medical devices have been the subject of Food and Drug Administration (FDA) Class I recalls, the FDA’s recall level that indicates products have the potential to cause terrible injuries, significant pain and even death.

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Pseudomonas aeruginosa: DermaFreeze365™ Instant Line Relaxing Formula

March 23, 2007 - Woodridge Labs, Inc., has voluntarily recalled all lots of its DermaFreeze365™ Instant Line Relaxing Formula (UPC Codes 6-05923-36501-6, 6-05923-36502-3 and 6-05923-10563-6) and DermaFreeze365™ Neck & Chest (UPC Code 6-05923-36503-0) products. This recall was a result of certain limited lots testing positive for the Pseudomonas aeruginosa bacteria. Learn more about the recall of DermaFreeze365.

Withdrawal of Equate and Member's Mark Wet Wipes
November 17, 2006 -- Rockline Industries announced that it has initiated a voluntary nationwide product withdrawal to the retail level of certain lots of its store brand wet wipes—Equate and Member’s Mark wet wipes sold at Wal-Mart and Sam’s Club. The voluntary withdrawal is a result of routine product testing that detected the presence of a micro-organism known as Burkholderia cepacia (B. cepacia). Learn more about the recall of Equate and Member's Mark wet wipes due to Burkholderia cepacia.

Donor Referral Services and HIV, Hepatitis B and Hepatitis C
The FDA has notified the health-care community that human tissue recovered by Donor Referral Services (DRS) may not have met FDA requirements for donor eligibility. Donor eligibility is determined through donor screening and donor testing. A donor is determined eligible to donate tissues only if the results of donor screening and donor testing indicate freedom from communicable diseases or communicable disease risks, including HIV-1 and 2, hepatitis B virus and hepatitis C virus. This means that anyone who received human tissue that originated with Donor Referral Services is at risk for HIV-AIDS, hepatitis B and hepatitis C. Learn more about Donor Referral Services and HIV, hepatitis B and hepatitis C.

Alaris® SE Pumps (formerly the Signature Edition Infusion Pumps)
Alaris® SE Pumps (formerly the Signature Edition Infusion Pumps) may cause serious harm or death. According to Cardinal Health, owner of Alaris Products, a “key bounce” in the Alaris infusion pumps may cause over-infusion of medications, possibly 10 times the amount intended. Upon the request of the FDA, the United States Marshall has seized defective Alaris infusion pumps. Learn more about Alaris SE infusion pumps.

Recall of One Lot of Azathioprine
Roxane Laboratories, Inc., has announced a recall of a single manufacturing lot of Azathioprine tablets, USP 50 mg, (NDC 00054-4084-25, Lot 558470A, Exp Mar 2009). It was discovered that a single bottle of Azathioprine tablets from lot 558470A contained Methotrexate tablets USP 2.5 mg. Learn more about the Azathioprine recall.

Disetronic D-TRONplus Power Pack Recall
Disetronic Medical Systems Inc. (Disetronic) of Fishers, IN announced today a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the real potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin delivery is interrupted. An interruption in insulin delivery may lead to uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to serious patient injury and/or death. Learn more about the Disetronic D-TRONplus Power Pack recall.

PIC50 External Monitor/Defibrillator
On July 7, 2006, the FDA announced the recall of 1,184 PIC50 External Monitor/Defibrillators manufactured in Buffalo Grove, Illinois between February 2002 and October of 2004 by MRL, Inc. a Welch Allyn Company. The recalled PIC50 monitor/defibrillators may display a DEFIB COMM ERROR, which may prevent or delay the delivery of therapy, which may fail to resuscitate the patient. Learn more about the PIC50 External Monitor/Defibrillator recall.

Triaminic Vapor Patch Recall
On June 19, 2006, the FDA announced the recall of Triaminic Vapor Patch products. According to the manufacturer, Novartis Consumer Health, serious adverse health effects, including seizures, could result if a Triaminic Vapor Patch is swallowed by a child who has removed the patch to chew on it. Learn more about the Triaminic Vapor Patch recall.

Reusable Ultrasound Transducer Assemblies
On June 19, 2006, the FDA issued a health notification regarding reusable ultrasound transducer assemblies used for various biopsy procedures. These instruments may not have been cleaned properly between uses. If you had a biopsy that involved the use of a reusable ultrasound transducer, you may be at risk for HIV/AIDS, hepatitis B, and hepatitis C. Learn more about biopsy procedures and HIV/AIDS, hepatitis B, and hepatitis C.

Recall of AED20 Automatic External Defibrillators
The Food and Drug Administration (FDA) has announced a June 15, 2006, recall of 580 AED20 automatic external defibrillators. According to the manufacturer, the recalled defibrillators may experience failure or unacceptable delay. Learn more about the recall of AED20 automatic external defibrillators.

Fusarium Keratitis Information
At the request of visitors to this site, we have gather information regarding Fusarium keratitis, the fungal eye infection linked to ReNu with MoistureLoc manufactured by Bausch & Lomb. Information includes an easy-to-understand definition, symptoms, treatment, and a brief explanation of possible product liability and medical malpractice cases. Learn more about Fusarium keratitis

Bausch & Lomb Recalls ReNu with MoistureLoc
May 15, 2006 – Almost exactly one month after withdrawing ReNu with MoistureLoc from the market, Bausch & Lomb officially recalls the product on a global basis. According to Bausch & Lomb, “unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection.” Learn more about the recall of Bausch & Lomb ReNu with MoistureLoc.

Renu Recall
We are no longer taking cases related to fungal eye infection outbreak and ReNu with MoistureLoc and ReNu MultiPlus.

Recall of Blackstone Medical's ICON Modular Fixation System
In April of 2006, the Food and Drug Administration (FDA) announced a recall of Blackstone Medical’s ICON Modular Fixation System. The ICON Modular Fixation System is used for spinal surgery.According to the recall notification, The construct can loosen in the early postoperative period. This requires surgery to remove the ICON Modular Fixation System. There have been 484 surgical procedures in which the recalled devices have been implanted. Learn more about the recall of Blackstone Medical's ICON Modular Fixation System.

Illegally Harvested Human Tissue Used in Surgical Procedures around the Country
The FDA recalled human tissue, including bones, skin, and tendons used for implants, grafts, and transplants. According to the FDA the tissue was illegally harvested from cadavers at funeral homes in New York City, Rochester, Philadelphia, and New Jersey. 4 officers of Biomedical Tissue Services (BTS) have been charged with illeaglly harvesting the tissue. The tissue was not screened or tested for HIV, Hepatitis B or C, or syphilis. The BTS issue was processed and/or distributed by Regeneration Technologies, LifeCell Corporation, Tutogen Medical, Inc., Lost Mountain Tissue Bank, and Blood and Tissue Center of Central Texas. Medtronic, Inc., of Minneapolis, Minnesota, also used BTS tissue for bone graft products.

Mesh Recall
We are no longer taking cases related to this recall.

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Firm News

Fred Pritzker Listed in The Best Lawyers in America

Fred Pritzker has been notified that he will again be listed in The Best Lawyers in America for his work in personal injury litigation.

Attorney Elliot Olsen Speaks at Conference

Attorney Elliot Olsen recently spoke at the Seventh Annual LifeScience Alley Conference in Minneapolis on Preemption and the Future of Medical Device Litigation. He appeared with Randall Pattee of Lindquist and Vennum and Jean Lance, VP of corporate legal and general counsel for Boston Scientific.

Zicam Lawsuit

Several lawsuits have been filed alleging Zicam caused loss of smell (anosmia) and taste, and our lawyers are reviewing potential claims. We are gathering information about Zicam smell loss. Read more about Zicam: Zicam class action lawsuit, warning letter from the FDA to Matrixx Initiatives, Inc. regarding Zicam Cold Remedy nasal spray and gel swabs, Zicam recall.

After only one use of a Zicam Cold Remedy product, Bonnie Blodgett lost her sense of smell. A gradening writer and foodie, her life was drastically changed. She recently published Remembering Smell: A Memoir of Losing--and Discovering--the Primal Sense in which she chronicals her experience with losing her sense of smell and then slowly getting it back again.

Bonnie's experience with Zicam is similar to many of our other clients. They experienced a burning sensation during the first use of a Zicam product and then lost their sense of smell (anosmia). Most of them were not as fortunate as Bonnie and have not regained their sense of smell.

For more information about Remembering Smell, please click on the image of the book.

Ortho Evra Lawsuit: Ortho Evra Birth Control Patch

The Ortho Evra birth control patch has been linked to an increased risk of blood clots that can lead to pulmonary embolism, stroke and heart attack.

Fentanyl Lawsuit and Fentanyl Recall

There have been a number of recalls regarding fentanyl due to the risk of a fentanyl overdose.

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