Z-2328-2021 Class II Ongoing
FDA device recall Z-2328-2021 was initiated by Boston Scientific Corporation on Jul 23, 2021 and is designated Class II. Reason for recall: Potential for leaks and loosening at the patient catheter connection The recall status is ongoing. Affected quantity: 4200 sets.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 25, 2021
- Initiation Date
- Jul 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4200 sets
Product Description
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Reason for Recall
Potential for leaks and loosening at the patient catheter connection
Distribution Pattern
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.
Code Information
GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2328-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026