TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
This recall is currently active, issued August 19, 2021. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- July 23, 2021
- Posted
- August 19, 2021
- Recall Number
- Z-2328-2021
- Quantity
- 4200 sets
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for leaks and loosening at the patient catheter connection
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.
Lot / Code Info
GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
Root Cause
Component change control
Action Taken
The firm disseminated a Medical Device Product Advisory on 07/23/2021 by overnight mail delivery. The letter explained the issue and directed users to ensure a firm connection is made between the outlet luer and the patient catheter prior to, and during ThersSphere administration.