Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Mindray DS USA, Inc. dba Mindray North America
- Reason for Recall:
- The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.
Product Codes/Lot Numbers:
All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1242-2018
Related Recalls
Potential for anesthesia leakage.
Potential for anesthesia leakage.
Potential for activation of an abnormal alarm pause.