Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Class I - DangerousWhat Should You Do?
- Check if you have this product: 8494465 8513227 8537103 8537104 8552050 8552051 8567256 8576963 8632766 8639366 8659206 8683459 8754089 NS8513228
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cook Inc.
- Reason for Recall:
- The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
Product Codes/Lot Numbers:
8494465 8513227 8537103 8537104 8552050 8552051 8567256 8576963 8632766 8639366 8659206 8683459 8754089 NS8513228
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0970-2020
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