TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Reported: August 25, 2021 Initiated: July 23, 2021 #Z-2327-2021
Product Description
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Reason for Recall
Potential for leaks and loosening at the patient catheter connection
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 4980 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.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE). Recalled by Boston Scientific Corporation. Units affected: 4980 sets.
Why was this product recalled? ▼
Potential for leaks and loosening at the patient catheter connection
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2327-2021.
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