Sorin Group USA, Inc. Smart Perfusion Pack, REF: 086500600, 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Smart Perfusion Pack, REF: 086500600, 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.
Brand
Sorin Group USA, Inc.
Lot Codes / Batch Numbers
Lot Number: 0933600001
Products Sold
Lot Number: 0933600001
Sorin Group USA, Inc. is recalling Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, due to Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA, WI
Page updated: Jan 10, 2026