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U.S. Department of Health and Human Services

Class 2 Device Recall INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir

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  Class 2 Device Recall INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir see related information
Date Initiated by Firm March 13, 2018
Create Date May 23, 2018
Recall Status1 Terminated 3
Recall Number Z-1918-2018
Recall Event ID 79863
510(K)Number K130209  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713

The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less
Code Information Lot: 1709190228, UDI: (01)08033178112352(17)200917(10)1709190228, Exp: 09/17/2020
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		 Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.
Quantity in Commerce 42
Distribution US Distribution to the states of : NJ, CA, MN, MO, MA
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 = DTZ and Original Applicant = SORIN GROUP ITALIA S.R.L.
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