Device Recall CareFusion Wet PVPI Vaginal Preoperative Skin Prep Tray

tray catalog number 4469A. tray lot numbers 0000312078, 0000312079, 0000313237, 0000315474, 0000317224, 0000317225, 0000317226, 0000319388, 0000319398, 0000319399, 0000319400, 0000321995, 0000326091, 0000330888, 0000331259, 0000331933, 0000333748, 0000333749, 0000333750, 0000336430, 0000336454, 0000340623, 0000342778, 0000342779, 0000342780, 0000344796, 0000347085, 0000348120, 0000351690, 0000354083, 0000356290, 0000361072, Y10S1161, Y10S1568, Y10S2006, Y10S2007, Y10S2364, Y10S2993, Y11A1149, Y11A2470, Y11A3023, Y11B0434, Y11B0955, Y11B1613, Y11B2924, Y11C0276, Y11C1279, Y11C1855, Y11C3087, Y11D0543, Y11D0779

Obstetrical and Gynecological Devices

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No

Nationwide Distribution including Arizona, California, Colorado, Connecticut, Florida, Illinois, Missouri, Nebraska, Nevada, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah and Virginia.

Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 10 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4469A || The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.