ClearanceBrief
Recall Z-0381-2017 ยท CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Teleflex Medical

LMA MADomizer, 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 failu

DateNov 9, 2016 (initiated Oct 27, 2016)
StatusTerminated
ReasonProduct Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Root causeProcess control
ActionTeleflex sent an Urgent Medical Device Recall Notification letter on/about October 27, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine affected products. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to Teleflex Customer Service or email to recalls@teleflex.com. For questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990. Teleflex sent an Amended Urgent Medical Device Recall Notification letter date
Quantity2,674,650 units in total
DistributionWorldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.