Recall Z-0381-2017
Teleflex Medical · initiated October 27, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 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.
Codes / lots: Product Code: MAD500, Lot # 160127, 160314, 160441, 160508, 160632 and 160805; Product Code: MAD510, Lot# 160109, 160115, 160206, 160220, 160227, 160303, 160315, 160323, 160328, 160401, 160426, 160501, 160519, 160603, 160612, 160622, 160633, 160702, 160719 and 160808.
Reason for recall
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
FDA-determined cause: Process control
Action taken
Teleflex 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 dated November 22, 2016, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to continue to return affected product for a full refund per the procedure set forth in the letter of October 27, 2016. Some customers have indicated that, due to medical necessity, they plan to continue using the affected lots rather than return them. Teleflex is advising all such customers to follow the supplemental instructions for Use included as Attachment B. These supplemental instructions allow non-destructive testing of each unit prior to the procedure to determine if it is defective. Institutions that intend to continue using affected lots with this supplemental testing, please send the acknowledgment form to recall@teleflex.com with their name and contact information and the lots that they will continue to use, or call 866-246-6990. Customers with questions should contact their local sales representative or Customer Service at 1-866-246-6990.
Details
- Recall number
- Z-0381-2017
- Initiated
- October 27, 2016
- Posted by FDA
- November 9, 2016
- Terminated
- September 25, 2020
- Product code
- CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- Quantity
- 2,674,650 units in total
- Distribution
- Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0382-2017 Class II | FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0383-2017 Class II | FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0384-2017 Class II | LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0385-2017 Class II | LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0386-2017 Class II | LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |
| Z-0898-2017 Class II | Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe…Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. | 10/27/2016Terminated |