Recall Z-1628-2018 ยท CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Teleflex Medical Europe Ltd
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
| Date | Mar 19, 2018 |
| 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 | The recall notice was disseminated by letter on 03/19/2018. The letter stated the following: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number 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 instruction |
| Quantity | 25 units |
| Distribution | TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.