AVID Medical—Various Procedure Trays and Kits: Aspergillus penicillioides Growth May Occur [FDA Class I]
June 9, 2021 | Strategic Insights for Health System
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Problem: FDA's Center for Devices and Radiological Health (CDRH) states that the BD ChloraPrep 3 mL applicators contained in the above kits may grow Aspergillus penicillioides, which may result in a breach of the package integrity. If a breach of package integrity occurs, other components in the kits may become contaminated. FDA's CDRH also states that the manufacturer initiated a recall by Urgent Medical Device Correction letter on April 9, 2021. The manufacturer has not confirmed the...