7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D
  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:
Churchill Medical Systems, Inc.
Reason for Recall:
Potential for leaking caused by insufficient bond between needleless device and female luer.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

Product Codes/Lot Numbers:

1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1473-2015

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