FDA Device recall Z-0386-2017
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal,…
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal,… by Teleflex Medical, citing product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0386-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-27 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Reason
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Identifiers
| code_info | Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0386-2017%22
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