Reported Dec 28, 2016 · Terminated
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of…
Teleflex Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Teleflex Medical · 2917 Weck Dr · Research Triangle Park, NC · 27709-0186
Is this the product you have?
- LMA MADgic, Atomization Device with 3mL Syringe, Rx only
- Product UsageThese 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
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published MAD600Lot# 160110, 160119m, 160128, 160140, 160207, 160228, 160304, 160411, 160442, 160525, 160703 and 160807 MAD700Lot# 160111, 160129, 160141, 160209, 160233, 160316, 160329, 160403, 160431, 160502, 160520, 160604, 160624, 160634, 160712, 160809 and 160818 MAD720Lot# 160142, 160404, 160511, 160725 and 160909 MAD730Lot# 160427 MAD730OSLot# 160305. - Amount recalled
- 2,674,650 units in total
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
This product could cause temporary or reversible health problems — stop using it.
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