Recalls for CLR Medicals International Inc.

CLR Medicals International Inc. Viscoelastic Products: Recall - Quality System Deficiencies And Lack Of Premarket Approval (PMR)
11/26/2013 Medical Recall

Clinical consequences associated with use of the contaminated and/or adulterated products may include intraocular infection, inflammation and elevated intraocular pressure.

  • Company:
    CLR Medicals International Inc.
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.