Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-3212-2017 · Posted 2017-08-25

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeCCT
Date Initiated2017-07-05
Date Terminated2018-11-20
Product Quantity135,456 units

Reason for Recall

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

Firm Action

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 [email protected]. 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 [email protected]. This will allow us to document your receipt of this letter." For questions regarding this recall call 866-246-6990.

Root Cause

Process control

Distribution Pattern

Nationwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑