FDAClass IIMay 24, 2023

WATCHDOG Hemostasis Valve Kit recall

WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

Why was WATCHDOG Hemostasis Valve Kit recalled?

The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565

Product
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Recalling firm
Boston Scientific Corporation
Quantity
1300 units
Distribution
Worldwide
Recall date
May 24, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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