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U.S. Department of Health and Human Services

Class 2 Device Recall Spectrum Medical Quantum Standard heat exchanger

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  Class 2 Device Recall Spectrum Medical Quantum Standard heat exchanger see related information
Date Initiated by Firm March 22, 2021
Date Posted August 12, 2021
Recall Status1 Terminated 3 on April 22, 2024
Recall Number Z-2277-2021
Recall Event ID 88267
510(K)Number K200201  
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Product Spectrum Medical Quantum Standard heat exchanger
Code Information Batch Numbers: B000129, C000415, C000416, C000417
Recalling Firm/
Manufacturer		 QURA S.R.L.
Via Di Mezzo 23
Mirandola Italy
Manufacturer Reason
for Recall		 Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
FDA Determined
Cause 2		 Material/Component Contamination
Action The firm notified their consignee of the problem by email beginning on 02/18/2021. They issued a recall noticed on 03/22/2021 by email.
Quantity in Commerce 1088 units
Distribution US Nationwide distribution in the state of South Carolina.
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.
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