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 |
Product Classification |
Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
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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
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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 |
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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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