TheraSphere Administration Set recall
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Why was TheraSphere Administration Set recalled?
Potential for leaks and loosening at the patient catheter connection
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
- Product
- TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 4200 sets
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.
- Recall date
- August 25, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)