TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
- Company
- Boston Scientific Corporation
- Recall Initiated
- July 23, 2021
- Posted
- August 19, 2021
- Recall Number
- Z-2327-2021
- Quantity
- 4980 sets
- Firm Location
- Maple Grove, MN
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 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
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.
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