Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code

FDA device recall Z-0898-2017 · posted 2016-11-09 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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.

Root cause

Process control

Status

Terminated

Product code

CCQ

Quantity affected

2,674,650 units in total

Distribution

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

Date initiated

2016-10-27

Date posted

2016-11-09

Date terminated

2020-09-25

Location

Research Triangle Park, NC