Recall Z-3212-2017 ยท CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Teleflex Medical
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
| Date | Aug 25, 2017 (initiated Jul 5, 2017) |
| Status | Terminated |
| Reason | Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label. |
| Root cause | Process control |
| 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 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 Ret |
| Quantity | 135,456 units |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device Teleflex Medical, Aug 19, 2016 |