🔍 RecallPedia

The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

Class I - Dangerous
🏥 Medical Devices Recalled: August 2, 2017 OriGen Biomedical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: N18487, N18487-1
  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:
OriGen Biomedical, Inc.
Reason for Recall:
Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

Product Codes/Lot Numbers:

Lot Numbers: N18487, N18487-1

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0021-2018

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