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

September 4, 2019 | Risk Management News

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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

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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