Pro-Dex—PDBP-001 Series PRO-DEX Surgical Driver Battery Packs: Sterile Packaging May Contain Particulates

September 4, 2019 | Strategic Insights for Health System


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FDA's Center for Devices and Radiological Health (CDRH) states that the sterile packaging of the above battery packs may contain particulates, potentially compromising product sterility. FDA's CDRH also states that the manufacturer initiated a recall by e-mail on September 25, 2018, and followed up by letter on September 26, 2018. The manufacturer has not confirmed the...

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