Reported Apr 4, 2018 · Terminated
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device…
Mindray DS USA, Inc. dba Mindray North America
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. dba Mindray North America · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- Gas Module 3 monitoring spirometer
- Part Number115-030108-00
- Product UsageThe 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
- Lot codes and dates
- All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
- Amount recalled
- 1719
Where it was sold
Why it was recalled
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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