Class 2 Device Recall CareFusion Wet PVPI Vaginal Preoperative Skin Prep Tray

• Date Initiated by Firm: February 07, 2012
• Date Posted: March 14, 2012
• Recall Status: Terminated on June 05, 2015
• Recall Number: Z-1209-2012
• Recall Event ID: 61103
• Product Classification: Applicator, vaginal - Product Code HGD
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Carefusion 2200 Inc; 1500 Waukegan Rd; Mpwm Bldg.; McGaw Park IL 60085-6728
• For Additional Information Contact: 847-473-1500
• Manufacturer Reason for Recall: The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution, which may represent a patient safety hazard.
• FDA Determined Cause: Packaging process control
• Action: CareFusion sent e-mails and follow-up Urgent Recall Notices dated February 7, 2012 to all of the affected customers on the same date, requesting that the customers follow the steps outlined below as mitigation until product can be replaced. 1. Please immediately destroy/discard or return any affected product you may have in-stock at your facility. Do NOT further distribute these products. 2. Forward this RECALL NOTICE to any customers to whom these products were sold notifying them of the potential risk (reference attachment for affected production lot numbers). End users must be advised to discard or return any CareFusion Skin Prep Tray with the noted product/lot number; distributors should manage this return process per their internal procedures. End users MUST NOT use these products. 3. Complete and return the attached Acknowledgement Form indicating that they have received this RECALL NOTICE and that they will communicate the Recall Notice to all customers who have purchased CareFusion Preoperative Skin Prep Tray catalog numbers 4420, 4468, and 4469A. 4. Contact CareFusion Customer Service at (800) 523-0502 ext. 53576 for details on return and/or replacement of stock.
• Quantity in Commerce: 100,570 trays
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.