Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
- 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:
- Merit Medical Systems, Inc.
- Reason for Recall:
- Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Product Codes/Lot Numbers:
UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1434-2025
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