—#151946

Product

Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

FDA product code: CCQ — Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Product code MAD100, Batch/Lot numbers 160105, 160137, 160302, 160321, 160402, 160435, 160506, 160523, 160609, 160620, 160707, 160802, 160813; Product code MAD100OS, Batch/Lot numbers 160322, 160524, 160630; Product code MAD110, Batch/Lot numbers 160217, 160507; Product code MAD110OS, Batch/Lot numbers 160240, 160312; Product code MAD130, Batch/Lot numbers 160107, 160138, 160517; Product code MAD130OS, Batch/Lot numbers 160436, 160803; Product code MAD140, Batch/Lot numbers 160125, 160218, 160437, 160610, 160801; Product code MAD140OS, Batch/Lot numbers 160226, 160438, 160727; Product code MAD300, Batch/Lot numbers 160108, 160117, 160126, 160145, 160146, 160200, 160219, 160225, 160231, 160300, 160313, 160327, 160400, 160409, 160422, 160432, 160440, 160500, 160518, 160602, 160611, 160621, 160631, 160701, 160708, 160718, 160728, 160800, 160804, 160814, 160816, 160823; Product code MAD300B, Batch/Lot number 160410.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186

Distribution

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

Timeline

Recall initiated: 2016-10-27
Posted by FDA: 2016-11-09
Terminated: 2020-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151946. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.