Recall Z-1596-2013 ยท MED Sterilant, Medical Devices
Steris Corporation
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
| Date | Jun 26, 2013 (initiated Mar 4, 2013) |
| Status | Terminated |
| Reason | During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models. |
| Root cause | Labeling Change Control |
| Action | STERIS sent a Customer Notification letter dated February 19, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to replace their existing labels with labels they provided in their customer notification package. We apologize for any inconvenience this may have caused you and as always STERIS Corporation is dedicated to support our products and valued Customers. If you have any questions regarding this matter, please contact your STERIS Capital Account Manager. For further questions ple |
| Quantity | QLC1677E: 38; QRC1699E: 128 & QPC1721E/QFC1683E: 0 |
| Distribution | Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113520 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation, Feb 21, 2012 |