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U.S. Department of Health and Human Services

Class 3 Device Recall Sorin Group Smart Perfusion Pack EPack

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  Class 3 Device Recall Sorin Group Smart Perfusion Pack EPack see related information
Date Initiated by Firm December 19, 2017
Create Date February 21, 2018
Recall Status1 Terminated 3 on August 11, 2020
Recall Number Z-0664-2018
Recall Event ID 79000
510(K)Number K981613  
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
Product Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Code Information Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
Recalling Firm/
Manufacturer		 LivaNova USA
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information Contact Joan Ceasar
281-228-7260
Manufacturer Reason
for Recall		 The product is labeled with the incorrect expiration date.
FDA Determined
Cause 2		 Process control
Action The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.
Quantity in Commerce 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
Distribution Distribution was made to one consignee in LA.
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 = DWE and Original Applicant = COBE CARDIOVASCULAR, INC.
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