🔍 RecallPedia

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F

Class I - Dangerous
🏥 Medical Devices Recalled: January 17, 2017 OriGen Biomedical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: N18487, N18487-1, N18561-1, R19169
  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:
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F

Product Codes/Lot Numbers:

Lots: N18487, N18487-1, N18561-1, R19169

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1232-2019

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