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.
FDA Recall Z-1596-2013 · Posted 2013-06-26
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Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMED
Date Initiated2013-03-04
Date Terminated2013-07-02
Product QuantityQLC1677E: 38; QRC1699E: 128 & QPC1721E/QFC1683E: 0
Reason for Recall
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.
Firm 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 please call (440)392-7348
Root Cause
Labeling Change Control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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