Recall Z-1492-2022
Boston Scientific Corporation · initiated May 25, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234
Reason for recall
Product may be mislabeled.
FDA-determined 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.
Details
- Recall number
- Z-1492-2022
- Initiated
- May 25, 2022
- Product code
- QEY – Mechanical Thrombolysis Catheter
- Quantity
- 10 units
- Distribution
- US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1491-2022 Class II | EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that…Product may be mislabeled. | 05/25/2022Open, Classified |