🔍 RecallPedia

Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

Class I - Dangerous
🏥 Medical Devices Recalled: March 14, 2024 Merit Medical Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # H2800643/ UDI: 00884450770757
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

Product Codes/Lot Numbers:

Lot # H2800643/ UDI: 00884450770757

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1874-2024

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