Overview of recall records associated with QURA S.R.L., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
This page summarizes recall records in which the official source identifies QURA S.R.L. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
