LMA MADomizer recall
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal…
Why was LMA MADomizer recalled?
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
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?
Product Code: MAD500, Lot # 160127, 160314, 160441, 160508, 160632 and 160805; Product Code: MAD510, Lot# 160109, 160115, 160206, 160220, 160227, 160303, 160315, 160323, 160328, 160401, 160426, 160501, 160519, 160603, 160612, 160622, 160633, 160702, 160719 and 160808.
- Product
- LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal…
- Recalling firm
- Teleflex Medical
- Quantity
- 2,674,650 units in total
- Distribution
- Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
- Recall date
- December 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)