Recalls for Viscocel and Viscocel Plus

CLR Medicals International Inc. Issues Nationwide Recall of Viscoelastic Products
11/26/2013 Food Recall

CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the Quality System regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human and animal use, have been determined to be a public health concern due to distribution in the US without FDA approval, which evaluates the safety and efficacy of the product, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products.

  • Company:
    CLR Medicals International Inc.
  • Problem
    Products were distributed in the US without FDA approval and violate QSR regulations related to sterility and biocompatibility that may result in the release of contaminated products.