Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B recall: Endotoxin
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance…
Why was Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Description: PERFUSION M484901D 1/B. Model Number: M484901D. GTIN: 00763000240288. Lot Number: 220906731.
- Product
- Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance…
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 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
- Recall date
- March 24, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)