Class 2 Device Recall Terumo Custom Kit

• Date Initiated by Firm: June 08, 2010
• Date Posted: August 02, 2010
• Recall Status: Terminated on May 07, 2012
• Recall Number: Z-2156-2010
• Recall Event ID: 56037
• 510(K)Number: K823451
• Product Classification: Cardiovascular Procedure Kit - Product Code DTR
• Product: Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP
• Code Information: Lots: ME05, ME26, MF03
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 28 Howe St; Ashland MA 01721-1305
• For Additional Information Contact: SAME; 800-283-7866 Ext. 7420
• Manufacturer Reason for Recall: Vent port may be occluded and prevent delivery of fluid
• FDA Determined Cause: Equipment maintenance
• Action: Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
• Quantity in Commerce: 32 packs
• Distribution: Distribution USA and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DTR