Z-0898-2017Class II

Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter...

Name: Z-0898-2017 Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter...
Creator: Teleflex Medical
Published: 2016-10-27
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-10-27 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS... on 2016-10-27. FDA classified it as Class II and gives the reason as "Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0898-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-27
Posted: 2016-11-09
Terminated: 2020-09-25
Recalling firm: Teleflex Medical
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
Product code: CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Reason for recall: Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]. 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 [email protected] 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.
Quantity in commerce: 2,674,650 units in total
Distribution: Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0898-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0381-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0382-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0383-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0384-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0385-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0386-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0898-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code CCQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)