Recall Z-1208-2012
Carefusion 2200 Inc · initiated February 7, 2012
Product
Wet PVP-I 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; 20 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 4468 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.
Codes / lots: tray catalog number 4468. tray lot numbers 0000310407, 0000310409, 0000310411, 0000310413, 0000312077, 0000312080, 0000312081, 0000313225, 0000313227, 0000313229, 0000313233, 0000313523, 0000314761, 0000314762, 0000315476, 0000315477, 0000315478, 0000315480, 0000317227, 0000317229, 0000317230, 0000317231, 0000318349, 0000318350, 0000318351, 0000318352, 0000319401, 0000319402, 0000319403, 0000319404, 0000319405, 0000321997, 0000321998, 0000321999, 0000322000, 0000322001, 0000323739, 0000323740, 0000323741, 0000326095, 0000326097, 0000326099, 0000326100, 0000326101, 0000326103, 0000326104, 0000328472, 0000328473, 0000328474, 0000328475, 0000328497, 0000328502, 0000328504, 0000330880, 0000330881, 0000330884, 0000330885, 0000330886, 0000333712, 0000333754, 0000333755, 0000333756, 0000333757, 0000333758, 0000333759, 0000333761, 0000333762, 0000336431, 0000336433, 0000336434, 0000336435, 0000336437, 0000336439, 0000336442, 0000336448, 0000336449, 0000336450, 0000336451, 0000336452, 0000336453, 0000342781, 0000342782, 0000342783, 0000342785, 0000342786, 0000342787, 0000342788, 0000342789, 0000342790, 0000344054, 0000344798, 0000344800, 0000344810, 0000344811, 0000344812, 0000347086…
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 taken
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.
Details
- Recall number
- Z-1208-2012
- Initiated
- February 7, 2012
- Posted by FDA
- March 14, 2012
- Terminated
- June 5, 2015
- Product code
- OJU – Skin Prep Tray
- Quantity
- 1,505,140 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.
- Recalling firm
- Carefusion 2200 Inc, McGaw Park, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1207-2012 | Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle…The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also… | 02/07/2012Terminated |
| Z-1209-2012 | Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone…The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also… | 02/07/2012Terminated |