FDA Device recall Z-0384-2017
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via…
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via… 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-0384-2017 |
| 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 MADgic, Atomization Device with 3mL Syringe, 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: MAD600, Lot# 160110, 160119m, 160128, 160140, 160207, 160228, 160304, 160411, 160442, 160525, 160703 and…Product Code: MAD600, Lot# 160110, 160119m, 160128, 160140, 160207, 160228, 160304, 160411, 160442, 160525, 160703 and 160807; Product Code: MAD700, Lot# 160111, 160129, 160141, 160209, 160233, 160316, 160329, 160403, 160431, 160502, 160520, 160604, 160624, 160634, 160712, 160809 and 160818; Product Code: MAD720, Lot# 160142, 160404, 160511, 160725 and 160909; Product Code: MAD730, Lot# 160427; Product Code: MAD730OS, Lot# 160305. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0384-2017%22
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