🔍 RecallPedia

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391

Class I - Dangerous
🏥 Medical Devices Recalled: July 21, 2021 Merit Medical Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # H2069291
  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:
There is a potential that a package sheath contains an incorrect dilator.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391

Product Codes/Lot Numbers:

Lot # H2069291

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2243-2021

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