🔍 RecallPedia

Capnostream20 (US) N REFURBISHED, Part Number CS78651

Class I - Dangerous
🏥 Medical Devices Recalled: July 31, 2018 Oridion Medical 1987 Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    B200001005 B200001300 B200001477 B200001546 B200001548 B200001557 B200001560 B200001582 B200001583 B200001591 B200001598 B200001601 B200001603 B200001606 B200001631 B200001641 B200001817 B200001884 B200001920 B200001938 B200001977 B200001986 B200002051 B200002060 B200002070 B200002078 B200002134 B200002148 B200002163 B200001387 B200001569 B200001673 B200001679 B200001844 B200002025 B200002031 B200002145 B200001827 B200001137 B200001160 B200001310 B200001660 B200001872 B200002187 B400002132 B200001671
  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:
Oridion Medical 1987 Ltd.
Reason for Recall:
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Capnostream20 (US) N REFURBISHED, Part Number CS78651

Product Codes/Lot Numbers:

B200001005 B200001300 B200001477 B200001546 B200001548 B200001557 B200001560 B200001582 B200001583 B200001591 B200001598 B200001601 B200001603 B200001606 B200001631 B200001641 B200001817 B200001884 B200001920 B200001938 B200001977 B200001986 B200002051 B200002060 B200002070 B200002078 B200002134 B200002148 B200002163 B200001387 B200001569 B200001673 B200001679 B200001844 B200002025 B200002031 B200002145 B200001827 B200001137 B200001160 B200001310 B200001660 B200001872 B200002187 B400002132 B200001671

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0032-2019

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Oridion Medical 1987

Class I - Dangerous

Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.

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