Gas Module 3 monitoring spirometer recall
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…
Why was Gas Module 3 monitoring spirometer recalled?
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14, 2008 and October 2015.
- Product
- 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…
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 1719
- Distribution
- Worldwide Distribution - U.S. Nationwide in the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY, including Puerto Rico and distributed to 30 foreign consignees.
- Recall date
- April 4, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)