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.
- Company
- Boston Scientific Corporation
- Recall Initiated
- May 25, 2022
- Recall Number
- Z-1492-2022
- Quantity
- 10 units
- Firm Location
- Maple Grove, MN
Reason for Recall
Product may be mislabeled.
Distribution
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Lot / Code Info
UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234
Root Cause
Under Investigation by firm
Action Taken
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.