Z-1592-2023 Class II Ongoing
FDA device recall Z-1592-2023 was initiated by Boston Scientific Corporation on April 5, 2023 and is designated Class II. Reason for recall: The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. The recall status is ongoing. Affected quantity: 1300 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1300 units
Product Description
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Reason for Recall
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Distribution Pattern
Worldwide
Code Information
GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565