FDAFDA · Food and drugs·Recall number Z-1592-2023
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Published May 24, 2023 · Recall initiated: April 5, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide
- Lot
- GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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