A recent massive medical device recall is the biggest single-day recall event on record for the U.S. Food and Drug Administration, according to a Regulatory Affairs Professionals Society report.
On Aug. 29, the FDA posted 233 Class I recalls for devices manufactured by Puerto Rico-based Customed on its website, according to the report. Every device was recalled due to errors in packaging.
A Customed news release indicated "the products have been found to have a potential defect due to adhesion. The defect could result in laws of product sterility and lead to infection."
There have been no reports of serious injuries or deaths reported to the FDA yet, according to the report.
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