Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot / GTIN Number / Use By: 1. 23485544 / 8714729939450 / 2021-02-10, 23933296 / 8714729939450 /2021-05-10, 23947883 / 8714729939450 / 2021-05-12, 24137846 / 8714729939450 / 2021-06-17. 2. Lots: 21305995 / 8714729939474 / 2019-09-25, 24201181 / 8714729939474 / 2021-06-30.
  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:
Boston Scientific Corporation
Reason for Recall:
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.

Product Codes/Lot Numbers:

Lot / GTIN Number / Use By: 1. 23485544 / 8714729939450 / 2021-02-10, 23933296 / 8714729939450 /2021-05-10, 23947883 / 8714729939450 / 2021-05-12, 24137846 / 8714729939450 / 2021-06-17. 2. Lots: 21305995 / 8714729939474 / 2019-09-25, 24201181 / 8714729939474 / 2021-06-30.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0578-2020

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