Z-1196-2021 Class I Terminated
FDA device recall Z-1196-2021 was initiated by Medtronic Perfusion Systems on February 4, 2021 and is designated Class I. 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. The recall status is terminated (terminated April 26, 2024). Affected quantity: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 4, 2021
- Termination Date
- April 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). 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).
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.
Distribution Pattern
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
Code Information
Description: CUSTOM PACK BB10H89R4 ECLR. Model Number: BB10H89R4. GTIN: 00763000126315. Lot Number: 220265395.