Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501001, 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 Recall Z-0382-2011 · Posted 2010-11-15
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Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2010-10-07
Date Terminated2010-12-17
Product Quantity19
Reason for Recall
Defective product packaging may compromise product sterility.
Firm Action
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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
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.
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