🔍 RecallPedia

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

Class I - Dangerous
🏥 Medical Devices Recalled: August 12, 2024 Merit Medical Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    REF/UDI-DI/Lot (Expiration Date): PSI-7F-11-038 Version F/00884450708835/H2874685 (09-Mar-2027), H2878374 (26-FEB-2027), H2904232 (11-MAY-2027)
  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:
7F sheath introducers labeled as 7.5F
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

Product Codes/Lot Numbers:

REF/UDI-DI/Lot (Expiration Date): PSI-7F-11-038 Version F/00884450708835/H2874685 (09-Mar-2027), H2878374 (26-FEB-2027), H2904232 (11-MAY-2027)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3190-2024

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