Z-3212-2017 Class II Terminated
FDA device recall Z-3212-2017 was initiated by Teleflex Medical on July 5, 2017 and is designated Class II. Reason for recall: Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label. The recall status is terminated (terminated November 20, 2018). Affected quantity: 135,456 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2017
- Initiation Date
- July 5, 2017
- Termination Date
- November 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135,456 units
Product Description
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
Reason for Recall
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Distribution Pattern
Nationwide distribution
Code Information
Lot Numbers: (a) MAD600 MADgic: 161217, 161218, 161228 (b) MAD700 MADgic: 161119, 161120, 161121, 161153, 161173, 161212, 161223, 161236 (c) MAD720 MADgic: 161154