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.
Recall
- Recall Number
- Z-1492-2022
- Event Number
- 90528
- Firm
- Boston Scientific Corporation
- FEI Number
- 3002095335
- Product Code
- QEY
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 25, 2022
- Address
- 1 Scimed Pl, Maple Grove, MN, 55311-1565
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.
Product may be mislabeled.
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.
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
10 units