Recall Z-1207-2012 ยท OJU Skin Prep Tray
Carefusion 2200 Inc
Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL 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 a
| Date | Mar 14, 2012 (initiated Feb 7, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root 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 t |
| Quantity | 38,440 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.