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U.S. Department of Health and Human Services

Class 3 Device Recall Smart Perfusion Pack

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  Class 3 Device Recall Smart Perfusion Pack see related information
Date Initiated by Firm July 03, 2019
Create Date February 27, 2020
Recall Status1 Terminated 3 on July 09, 2021
Recall Number Z-1389-2020
Recall Event ID 84732
510(K)Number K981613  
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
Product LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
Code Information Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141  Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette
Recalling Firm/
Manufacturer		 LivaNova USA Inc.
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information Contact Njemile Crawley
281-228-7575
Manufacturer Reason
for Recall		 Perfusion tubing pack was packaged with the incorrect cuvette.
FDA Determined
Cause 2		 Employee error
Action On 07/03/2019, the firm contact it customers in person and on 07/08/2019 sent a "MEDICAL DEVICE CORRECTION" Letter informing them of the incorrect cuvette was assembled into Perfusion Pack 046008200 (Lot Number 1912100141) and instructed the customers to: 1. Please check their inventory for PTS pack 046008200, with lot number 1912100141 delivered to their facility; 2. Using the attached Customer Response Form (Attachment 1), please respond by email to USFSN@livanova.com to confirm that they have affected products in their facility; 3. All PTS pack 046008200 with lot number 1912100141 should not be used and should be returned. The Recalling Firm will be contacting its customers to organize the replacement of the affected products. 4. Ensure that this Medical Device Correction is communicated to all personnel within their organization who need to be aware of it. If the customer has 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. 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 27 packs
Distribution US Nationwide distribution in the state of IL.
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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