| Class 1 Device Recall Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir With Balance Biosurface | |
Date Initiated by Firm | February 04, 2021 |
Date Posted | March 17, 2021 |
Recall Status1 |
Terminated 3 on April 26, 2024 |
Recall Number | Z-1195-2021 |
Recall Event ID |
87271 |
510(K)Number | K183511 |
Product Classification |
Reservoir, blood, cardiopulmonary bypass - Product Code DTN
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Product | Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store blood during extracorporeal
circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing
with the venous blood, which is filtered. The primary blood-contacting surfaces
of the CVR are coated with Balance Biosurface to reduce platelet activation and
adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator). |
Code Information |
Description: CUSTOM PACK HY11B40R1 1/4 RESPIRATO. Model Number: HY11B40R1. GTIN: 00763000314231. Lot Number: 220911913. |
Recalling Firm/ Manufacturer |
Medtronic Perfusion Systems 7611 Northland Dr N Brooklyn Park MN 55428-1088
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For Additional Information Contact | Medtronic Customer Service 800-8543570 |
Manufacturer Reason for Recall | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
FDA Determined Cause 2 | Device Design |
Action | A written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. Consignees will also be asked to return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at800-854-3570 to initiate a product return. |
Quantity in Commerce | 4 units |
Distribution | Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam |
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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510(K) Database | 510(K)s with Product Code = DTN
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