Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). 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).
This recall has been terminated (originally issued March 17, 2021).
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- February 4, 2021
- Posted
- March 17, 2021
- Terminated
- April 26, 2024
- Recall Number
- Z-1191-2021
- Quantity
- 57 units
- Firm Location
- Brooklyn Park, MN
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
Description: OXYGENATOR BBP241 W/CVR NI BB STERILE. Model Number: BBP241. GTIN: 20613994617303. Lot Number: 13340434.
Root Cause
Device Design
Action Taken
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.