🔍 RecallPedia

Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

Class I - Dangerous
🏥 Medical Devices Recalled: May 2, 2018 Galt Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot #: a) 18032057, 18032058; b) 18001013, 18046016, 18162838; c) 18019455 18019456, 18019457, 18019458, 18019460, 18047461, 18047462, 18047463; d) 17363374, 18116090
  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:
Galt Medical Corporation
Reason for Recall:
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

Product Codes/Lot Numbers:

Lot #: a) 18032057, 18032058; b) 18001013, 18046016, 18162838; c) 18019455 18019456, 18019457, 18019458, 18019460, 18047461, 18047462, 18047463; d) 17363374, 18116090

Distribution:

Distributed in: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2562-2018

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