—#87984

Product

Smart Perfusion Pack, REF: 088504500, 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 product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K881330
Affected lot / code info: Lot Number: 0932800048.

Why it was recalled

Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004

Distribution

Distribution pattern: AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.

Timeline

Recall initiated: 2009-12-30
Posted by FDA: 2010-03-12
Terminated: 2010-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87984. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.