FDA Recall
Terminated
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: Z-1087-2010
·
Initiated December 30, 2009
Recall
- Recall Number
- Z-1087-2010
- Event Number
- 54250
- Firm
- Sorin Group USA, Inc.
- FEI Number
- 1718850
- Product Code
- DWF
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- December 30, 2009
- Posted
- March 12, 2010
- Terminated
- March 15, 2010
- Address
- 14401 W 65th Way, Arvada, CO, 80004
Description
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.
Reason
Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
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.
Distribution
AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
Quantity
2 units