TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Summary
The FDA issued a Class II for TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) by Boston Scientific Corporation. Reason: Potential for leaks and loosening at the patient catheter connection.
Details
Source
Device Recall
External ID
Z-2328-2021
Action Date
2021-08-25
Status
Ongoing
Category
device
Product Description
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Lot/Code Info: GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
Quantity Affected: 4200 sets
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-23
Company
Maple Grove, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2328-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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