EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC c
Summary
The FDA issued a Class II for EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a by Boston Scientific Corporation. Reason: Product may be mislabeled..
Details
Source
Device Recall
External ID
Z-1492-2022
Action Date
2022-08-10
Status
Ongoing
Category
device
Product Description
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Lot/Code Info: UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234
Quantity Affected: 10 units
Reason for Recall
Product may be mislabeled.
Distribution
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-25
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 97 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-1492-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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