Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: a) 18043101; b) 18124426, 18120765
  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:

Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

Product Codes/Lot Numbers:

Lot #: a) 18043101; b) 18124426, 18120765

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-2563-2018

Related Recalls