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FDA Announces Largest Ever Medical Device Recall

6310985_s-300x200 (1).jpgLast month, the U.S. Food and Drug Administration (FDA) issued a massive medical device recall that is the largest single-day recall ever. The recall involved devices made by Puerto Rico-based manufacturer Customed, Inc. and was given a Class I recall classification - the FDA's most serious recall classification , which is used in those cases where "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." According to an article by the Regulatory Affairs Professional Society (RAPS), the FDA typically recalls between 3 and 75 devices each day, with the overwhelming majority of those recalls either Class II or Class III recalls which reflect lesser (and non-deadly) safety risks than Class I. But on August 29, 2014, the FDA posted 233 Class I recalls, all of which were for devices manufactured by Customed due to packaging flaws. In a warning letter issued on August 26, 2014, the FDA recommended that customers who have products stop using the product lots included in the recall. Customed, Inc. has notified its distributors by mail and arranged for the products return. Customers with questions about this recall may contact Ms. Wanda Cotto, Recall Coordinator, at (787) 801-0100 Ext. 7540, Monday through Friday, 8:00 a.m. - 5:00 p.m., Eastern Time. The FDA also advises healthcare professionals and patients to report adverse events or side effects related to these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by:

  • Completing and submitting the report online at;
  • Downloading the form or calling 1-800-332-1088 to request a reporting form, then completing and returning the form to the address on the pre-addressed form or faxing to 1-800-FDA-0178.

Dangers of Defective Medical Devices

Medical devices - such as pacemakers, hip implants, and transvaginal mesh - are intended to correct a medical problem and improve a patient's health, but in some cases a medical device is dangerous or defective. In some cases, the medical device defect can be fixed relatively easily, but in other cases, the harm of a defective medical device can be catastrophic or even deadly. If you suspect that your medical device has failed or you have been injured by a medical device, you should consult with a healthcare professional to receive the appropriate medical care. In some cases, follow-up medical treatment or procedures may be required to repair any damage caused by the defective medical device.

Contact a Medical Device Lawyer

If you have concerns about a defective medical device, you should also contact a medical device lawyer. The Chicago medical malpractice lawyers at Steinberg, Goodman & Kalish are committed to protecting the public from dangerous medical products, including unsafe pharmaceuticals and defective medical devices. Contact our office at (888) 325-7299 to schedule a free consultation to discuss a possible product liability or medical malpractice claim.     Steinberg Goodman & Kalish  ( is dedicated to protecting victims and their families.  We handle medical malpractice, product liability, personal injury, wrongful death, auto accidents, professional negligence, birth trauma, and railroad law matters. Contact us at (888) 325-7299 or (312) 445-9084.

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