Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
FDA Recall Z-1098-2010 · Posted 2010-03-12
Advertisement
Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2009-12-30
Date Terminated2010-03-15
Product Quantity71 units
Reason for Recall
Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Firm Action
Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.
Root Cause
Packaging process control
Distribution Pattern
AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
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.
Advertisement