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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 EPacksee related information
Date Initiated by FirmDecember 19, 2017
Create DateFebruary 21, 2018
Recall Status1 Terminated 3 on August 11, 2020
Recall NumberZ-0664-2018
Recall Event ID 79000
510(K)NumberK981613 
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
ProductSorin 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
FEI Number 1718850
Recalling Firm/
Manufacturer		 LivaNova USA
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information ContactJoan Ceasar
281-228-7260
Manufacturer Reason
for Recall		The product is labeled with the incorrect expiration date.
FDA Determined
Cause 2		Process control
ActionThe recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.
Quantity in Commerce16 units (6 from lot 1717800062 and 10 units from lot 1720800071
DistributionDistribution was made to one consignee in LA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWE
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