Recall of Device Recall Viscocel and Viscocel Plus

Recall

66930

Class 1

Z-0531-2014

2013-11-25

2013-12-20

Terminated

United States

2014-12-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124229

Clr medicals international inc., initiated a nationwide recall of viscocel and viscocel plus, in response to fda inspection 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.

CLR Medicals initiated a nationwide recall on November 25, 2013, of Viscocel and Viscocel Plus, by issuing a press release,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. CLR Medicals International, Inc. sent a Medical Device Recall letter dated December 6, 2013, to all affected customers. The letter informed customers of the reason for recall, product description with manufacturing date range, possible health hazard, instructions on what to do with recalled product, and contact information for the firm and to report any adverse events to FDA MedWatch. The recall notification letter was accompanied by a response form. Customers with questions were instructed to call 909-398-1880. For questions regarding this recall call 909-398-1880.