🔍 RecallPedia

Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610

Class I - Dangerous
🏥 Medical Devices Recalled: May 25, 2022 Mckesson Medical-Surgical Inc. Corporate Office Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    GTIN: a. 20612479161539; 30612479162472 BX; 40612479161571 CS. b. 20612479161546; 30612479162489 BX; 40612479161588 CS
  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:
Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall:
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610

Product Codes/Lot Numbers:

GTIN: a. 20612479161539; 30612479162472 BX; 40612479161571 CS. b. 20612479161546; 30612479162489 BX; 40612479161588 CS

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1613-2022

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