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U.S. Department of Health and Human Services

Class 3 Device Recall Stockert S5 System

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  Class 3 Device Recall Stockert S5 System see related information
Date Initiated by Firm January 28, 2019
Create Date February 10, 2020
Recall Status1 Terminated 3 on January 31, 2022
Recall Number Z-1119-2020
Recall Event ID 84142
510(K)Number K071318  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594

Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Code Information Device Model, Catalog Number, Serial Number: SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0247 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0249 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0250 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0258 DATAPADIII WITHOUT SOFTWARE, 24-90-87, 17BQC0257
Recalling Firm/
Manufacturer		 LivaNova USA Inc.
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information Contact Customer Service
1800-986-4702
Manufacturer Reason
for Recall		 Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
FDA Determined
Cause 2		 Error in labeling
Action On 01/28/2019, a Medical Device Correction letter was mailed to affected consignees. The letter asked customers to take the following actions: 1. Please check your inventory using the list of affected products delivered to your facility in Attachment 1; 2. Using the attached Customer Response Form (Attachment 2), please respond by email to USFSN@livanova.com to confirm that you have affected products in your facility. Your LivaNova reference person will contact you for the replacement of the product labels with labels bearing the correct manufacturing date. 3. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be aware of it. If you have transferred any of the affected devices to a third party, please communicate this information to them and inform the LivaNova Quality Assurance Team at USFSN@livanova.com. 4. For questions regarding this Medical Device Correction, please contact us at (800) 986-4702 or by e-mail to USFSN@livanova.com.
Quantity in Commerce 5 Datapads
Distribution US: NJ and CA
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 = DTQ and Original Applicant = SORIN GROUP DEUTSCHLAND GMBH
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