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U.S. Department of Health and Human Services

Class 2 Device Recall MAD

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  Class 2 Device Recall MAD see related information
Date Initiated by Firm October 27, 2016
Date Posted November 09, 2016
Recall Status1 Terminated 3 on September 25, 2020
Recall Number Z-0898-2017
Recall Event ID 75554
Product Classification Nebulizer, medicinal, non-ventilatory (atomizer) - Product Code CCQ
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
Code Information 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. 
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Alice Harper
610-378-0131 Ext. 3548
Manufacturer Reason
for Recall		 Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 2,674,650 units in total
Distribution Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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