🔍 RecallPedia

Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.

Class I - Dangerous
🏥 Medical Devices Recalled: March 8, 2024 ROUTE 92 MEDICAL Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601
  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:
ROUTE 92 MEDICAL INC
Reason for Recall:
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.

Product Codes/Lot Numbers:

UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1612-2024

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