Medline—PVP Scrub Solution: May Not Meet Iodine Assay Level Requirements to Support Labeled Expiration Date​

February 28, 2018 | 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 Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a February 15, 2018, Product Recall Notification Immediate Action Required letter submitted by ECRI Institute member hospitals, Medline states that the above solution may not meet the iodine assay level requirements to support the labeled expiration date. Medline also states that the reported iodine assay level is still within the safe and effective range for Povidone-Iodine Healthcare Antiseptics as documented in the Tentative Final Monograph for OTC Healthcare Antiseptic Drug Products. The manufacturer has not confirmed the...

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