—#95264

Product

Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by 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 No. 1013100022, 1016700043, 1018200024, 1022300025

Why it was recalled

Defective product packaging may compromise product sterility.

Root cause (FDA determination)

Packaging process control

Action the firm took

Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible. For further information, contact 1-800-650-2623.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.

Timeline

Recall initiated: 2010-10-07
Posted by FDA: 2010-11-15
Terminated: 2010-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95264. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.