🔍 RecallPedia

LoFric Origo, Nelaton, 16in, FR10 urinary catheters

Class I - Dangerous
🏥 Medical Devices Recalled: June 17, 2020 Wellspect HealthCare (Division of DENTSPLY IH AB) Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # 447123
  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:
Wellspect HealthCare (Division of DENTSPLY IH AB)
Reason for Recall:
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

LoFric Origo, Nelaton, 16in, FR10 urinary catheters

Product Codes/Lot Numbers:

Lot # 447123

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2643-2020

Related Recalls