Device product
FLEXI NOZZLE SHORT 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.
Z-0383-2017
Product summary
- Firm
- Teleflex Medical
- Event
- Event 75554
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,674,650 units in total
- Official record key
device-enforcement:Z-0383-2017
Official wording
Reason: Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Code information: Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.
Distribution pattern: Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
Derived failure modes
-
Unknown
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.