🔍 RecallPedia

MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765

Class I - Dangerous
🏥 Medical Devices Recalled: January 30, 2024 Angiodynamics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 15051684023085 UPN: H965457651 Lot Number: 5790681 5795961 5800479 5803518 5805067
  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:
Angiodynamics, Inc.
Reason for Recall:
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765

Product Codes/Lot Numbers:

UDI: 15051684023085 UPN: H965457651 Lot Number: 5790681 5795961 5800479 5803518 5805067

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1343-2024

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