—#158408

Product

LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region

FDA product code: CCT — Applicator (Laryngo-Tracheal), Topical Anesthesia
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K153470
Affected lot / code info: Lot Numbers: (a) MAD600 MADgic: 161217, 161218, 161228 (b) MAD700 MADgic: 161119, 161120, 161121, 161153, 161173, 161212, 161223, 161236 (c) MAD720 MADgic: 161154

Why it was recalled

Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

Root cause (FDA determination)

Process control

Action the firm took

Teleflex sent an Urgent Medical Device Recall Notification letter on July 5, 2017, to all affected customers. The letter directed the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter." For questions regarding this recall call 866-246-6990.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution

Timeline

Recall initiated: 2017-07-05
Posted by FDA: 2017-08-25
Terminated: 2018-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #158408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.