Penumbra Jet 7 Xtra Flex Catheter Recall

The Food and Drug Administration (FDA) announced today that Penumbra has recalled all units of the Penumbra Reperfusion Catheter with Xtra Flex Technology (Jet 7 Xtra Flex) due to increased risk of serious injury and death while removing blood clots in stroke patients.

Free Consultation

The Penumbra Jet 7 catheter recall comes after the FDA received over 200 medical device reports detailing issues with the catheter, including serious injuries such as hemorrhages, blood vessel damage, and death. Twenty of these reports involve patient deaths in procedures in which the catheter was used. The recalled JET 7 Xtra Flex catheter was intended to be used to remove blood clots in the brains of patients who have suffered acute ischemic strokes.

According to the FDA’s recall announcement, Penumbra’s testing found that the distal tip of the Jet 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other catheters also used to remove clots in stroke patients. As a result, the Jet 7 Xtra Flex catheter can balloon, expand, rupture, break, or completely separate in the middle of surgery. Such product failure may lead to catastrophic injuries.

Injuries associated with the Penumbra Jet 7 Xtra Flex Catheter Recall include:

  • Brain Bleeds
  • Hemorrhagic Strokes
  • Blood Vessel Damage
  • Death

Contact GoldenbergLaw

The catheter recall attorneys at GoldenbergLaw are currently representing individuals and the families of individuals who have suffered serious injuries or death due to the Penumbra Jet 7 Xtra Flex catheter. Contact us today for a free Penumbra Jet 7 lawsuit consultation. We have over 30 years of experience litigating defective medical device cases and have recovered tens of millions of dollars for our clients. Let us deliver the Gold standard advocacy you deserve.

 

Bacteria Discovered in Kimberly-Clark’s Wipes

Bacteria in Cottonelle Wipes

In October 2020, Kimberly-Clark announced the recall of Cottonelle Flushable Wipes and GentlePlus Flushable Wipes due to the presence of pluralibacter gergoviae bacteria, which can lead to infection. The wipes have been in high demand due to the pandemic.

Pluralibacter gergoviae bacteria is often found in soil, water, and sewage. It also appears in cosmetics, shampoo, and baby wipes.

The Recall

In October 2020, Kimberly-Clark voluntarily recalled select packages of Cottonelle Flushable Wipes and GentlePlus Flushable Wipes sold in the U.S., Canada, and Caribbean due to the bacterial contamination. The recall was limited to the wipes that were manufactured between February 7 and September 14, 2020.

The recall warned that the wipes may contain pluralibacter gergoviae, which is linked to serious infections in healthy individuals. Additionally, the recall mentioned that individuals with weak immune systems are at a heightened infection risk.

Lawsuits

In November 2020, Kimberly-Clark Corporation was hit with a proposed class action lawsuit in New York federal court with product liability claims in addition to alleging violations of New York’s false advertising laws. Plaintiff Dawn Rothfeld claimed in the lawsuit that she used Cottonelle Wipes for personal hygiene and that they were contaminated with pluralibacter gergoviae bacteria. The lawsuit stated that the bacteria caused a urinary tract infection, painful urination, and other symptoms. The plaintiff was treated with antibiotics but she also had to have ultrasounds of her abdomen and bladder. Even after all of these measures, Rothfeld still experiences weakness, nausea, and vomiting after using the Cottonelle Wipes between February and October 2020.

The lawsuit noted that “thousands of women have reported urinary-tract infections after using the wipes, which required doctor and hospitals visits, and Cottonelle’s social media accounts have been flooded with accounts of injuries relating to the products—many of which have gone undiagnosed due to the rare strain of bacteria at issue.”

The lawsuit claimed that the contamination occurred in February 2020 in certain lots of the wipes. It also alleges that Kimberly-Clark did not have safeguards to detect bacterial contamination. This is despite the wipes allegedly having dark brown spots on the surface and the packaging smelling like mildew—both being signs of bacterial contamination.

How GoldenbergLaw Can Help

The Minnesota Product Recall Attorneys at GoldenbergLaw have over thirty years of experience helping clients receive the justice they deserve by providing Gold standard advocacy. Leave the sleepless nights to us by contacting us today!

Lakeville, MN Company Recalls Tree Stands After Injuries

Tree Stands and Product Liability

As we approach the beginning of the 2020 firearm deer hunting season, we are reminded of how much hunters rely on their equipment. Hunters place their trust in equipment manufacturers to create products that will keep them safe and that trust is violated when a product is defective.

Defectively designed and manufactured tree stands place hunters at risk of severe injuries from falls and other accidents. Falls can lead to broken bones, spinal injuries, traumatic brain injuries, permanent injuries, and even death. If a tree stand manufacturer is aware of any defect, they are required to warn consumers and issue prompt safety recalls.

Bringing a product liability lawsuit holds the manufacturers accountable for hunting accidents and injuries relating to the defective equipment they designed and produced.

Tree Stand Accidents

Hunters are more likely to be injured in a fall from a tree stand than from an accidental gunshot. Hunters who fall from a tree stand 15 or fewer feet off the ground usually survive; however, hunters who fall from 24 feet or more off of the ground are more likely to suffer fatal injuries.

Data shows that a person who uses a tree stand for hunting has approximately a 5% chance of being injured while falling from a tree stand at some point in their hunting careers. The fact that these accidents usually occur in remote locations can take hours to transport victims to medical care can complicate the injuries.

What Happened?

The Lakeville outdoors hunting and recreation gear company, Alliance Outdoor Product Inc., is recalling thousands of tree stands after two users fell and suffered broken bones due to cable failures just days before firearms deer hunting season begins in Minnesota on Sunday, November 8, 2020 at sunrise.

The U.S. Consumer Product Safety Commission (CPSC) announced the recalls of approximately 3,400 X-Stand Tree Stands with the following model names: Silent Adrenaline and Apache.

The CPSC announced that the cable assemblies have come apart “due to corrosion, posing a fall hazard for the user” and there have been five reports of tree stand cables separating, with two people breaking bones. This is very concerning news given that Minnesota’s Department of Natural Resources estimates nearly 500,000 hunters will participate in hunting season and tree stands are popular hunting gear.

The 2017 model year tree stands were made in China and sold between May 2017 and December 2018 at retail outlets nationwide in addition to online shopping sources www.sportsmansguide.com and www.x-stand.com.

Read below for addition recall information:

The Silent Adrenaline model is XSCT334 with the following batch numbers being recalled:

  • 5X-1017
  • 5X-1517

The UPC code for the Silent Adrenaline stand is:

  • 816153011219

The Apache model is XSCT355 and the following batch number has been recalled:

  • 5X-5317

The UPC code for the Apache stand is:

  • 816153011677

How GoldenbergLaw Can Help

If you or a loved one has been injured by a defective tree stand, contact the Minnesota Product Liability Attorneys at GoldenbergLaw. We have over thirty years of experience providing the Gold standard of advocacy. Leave the sleepless nights to us by contacting GoldenbergLaw today!