LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic

FDA device recall Z-3212-2017 · posted 2017-08-25 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

CCT

Quantity affected

135,456 units

Distribution

Nationwide distribution

Date initiated

2017-07-05

Date posted

2017-08-25

Date terminated

2018-11-20

Location

Research Triangle Park, NC

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