| Class 2 Device Recall EkoSonic Endovascular Device | |
Date Initiated by Firm | May 25, 2022 |
Create Date | August 01, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1491-2022 |
Recall Event ID |
90528 |
510(K)Number | K213422 |
Product Classification |
Mechanical thrombolysis catheter - Product Code QEY
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Product | EkoSonic Kit 135cm, 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. |
Code Information |
UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact | Rebecca KinKead Rubio 763-494-1133 |
Manufacturer Reason for Recall | Product may be mislabeled. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The recalling firm notified affected consignees by telephone beginning May 25, 2022 to inform them of the potential of improperly packaged devices. On May 26, 2022, customer notifications, including a letter, instructions and reply form) were sent to all affected accounts via FedEx Overnight Delivery.
Consignees are asked to return any affected and unused devices to BSC. The field removal letter will provide customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form (RVTF) indicating they have received the field removal and followed the included instructions. |
Quantity in Commerce | 10 units |
Distribution | US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = QEY
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