🔍 RecallPedia

Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.

Class I - Dangerous
🏥 Medical Devices Recalled: October 3, 2019 Cook Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot Number 9502915
  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:
Cook Inc.
Reason for Recall:
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need for a repeat embryo transfer procedure, or the need for a patient to undergo an additional IVF cycle.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.

Product Codes/Lot Numbers:

Lot Number 9502915

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0415-2020

Related Recalls