Unreported Changes to Sterilization Wraps Draw FDA Warning

Kimberly-Clark Healthcare failed to obtain marketing clearance before selling 12 models of previously approved sterilization wraps that the FDA considers new products because significant changes were made, according to a warning letter.

The FDA says the devices are adulterated and misbranded because the company failed to provide adequate justification for not submitting 510(k)s or PMAs for the updated line. The company claimed the changes made between 1991–1995 were not significant enough to require new 510(k)s.

SOURCE: FDANEWS