U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Pack, hot or cold, water circulating - Product Code ILO
원인
The recall was initiated because breg has determined that some sterile polar pads products manufactured from january 2010 to october 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
조치
The firm, BREG, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product; complete the Return Response Form by email, Fax or mail; and contact Breg for a Return Authorization for the affected product and request replacement by contacting Breg Customer Care at 800-321-0607. Note: response is required even if you have no affected inventory.
Should you have any questions regarding this communication or need to report an adverse event, please contact Breg Customer Care at 800-321-0607.