• Surgical Packs Recalled by Customed
  • September 11, 2014 | Author: Seth A. Katz
  • Law Firm: Burg Simpson Eldredge Hersh & Jardine, P.C. - Englewood Office
  • After discovering a potential defect due to adhesion in its sterile convenience surgical packs, Customed, Inc. has issued a voluntary recall for the packs.

    The company noted the defect could cause the product to become unsterile, leading to infection. The packs were distributed across a wide array of hospitals and medical offices. The products wee distributed to facilities in Florida, New York, Puerto Rice and the U.S. Virgin Islands.

    Customed, Inc. said no serious injuries or deaths have occurred as a result of the recalled products. The surgical packs weren't the only product recently recalled in the medical community.

    4-Loop Vascular Retrieval Snare recall
    In a separate announcement, Cook Medical said it is voluntarily recalling 696 CloverSnare 4-Loop Vascular Retrieval Snare devices. The company noted the product isĀ  recalled because of a potential for the loop to separate from the shaft, which could cause the device to stop functioning, creating the potential for embolization of the fragments from the snare and a need to retrieve the separated snare through surgical intervention.

    The products were manufactured between Aug. 2012 and Aug. 2013 and were distributed from March 8, 2013 to July 1, 2014.

    The company indicated six customers reported cases where the loop of the snare became separated from the shaft. In four of those instances, medical intervention was required to retrieve the snare. The separation happened when a lateral force came into contact with the snare, changing the shape of the device. All affected customers have been notified of the recall by a letter from Cook Medical.