ClickCease Puerto Rico Medical Device Maker Faces Largest FDA Recall
09/18/14   |   By

Puerto Rico Medical Device Manufacturer Faces Largest FDA Recall Ever | DC Metro Area Personal Injury Law Blog

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Recently, the U.S. Food and Drug Administration (FDA) issued a recall of 233 medical devices in one of the largest one-day recall events in the agency’s history.

The recall, affecting products manufactured by Puerto Rico firm Customed, Inc., received a Class I designation, the organization’s most severe classification. While the vast majority of FDA recalls fall under the Class II category (indicating less deadly consequences), all the affected Customed devices had packaging flaws potentially leading to contamination and infection in patients.

To date, no patients have reported adverse effects from handling or using these items. However, with “several hundred thousand units” currently on the market, locating and eliminating the devices from medical facilities and homes has become a top priority for the FDA.

The Customed recall assumes the dubious distinction not only of being the FDA’s largest on record, but representing 9 times more affected products than its predecessor. Hurt By a Recalled Product? Here’s What to Do

As the number of product recalls increases, it’s important to take proactive and reactive measures to ensure your and your family’s safety. Even those making an effort to stay apprised of recent recalls may suffer harm from a recently recalled product, or even from one not yet recalled. When this happens, consider taking action such as:

  • Obtaining medical care. Go immediately to an urgent-care or emergency facility to have a doctor evaluate and treat injuries. Be sure to tell the intake worker your injury may be related to a product.
  • Retain documentation. Take pictures of the injury, product, and any other pertinent details, and retain any paperwork related to medical or other expenses you might incur.
  • Contact a defective products attorney. As soon as possible after the injury, reach out to a D.C. personal injury lawyer with experience handling cases involving defective products. Whether the product involved has been recalled or not, you deserve to know whether you are entitled to compensation for your suffering.

Manufacturers have a responsibility to keep their customers safe. When a company breaks your trust, explore all your legal options.


It’s not just medical devices that cause problems. Food products do, too. Check out Chicken Nugget Recall Sheds Light on Food Safety

Regan Zambri Long
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