| Class 2 Device Recall Teleflex MEDICAL LMA(TM) MADgic(TM) | |
Date Initiated by Firm | March 19, 2018 |
Create Date | May 23, 2018 |
Recall Status1 |
Terminated 3 on August 27, 2019 |
Recall Number | Z-1628-2018 |
Recall Event ID |
79643 |
Product Classification |
Applicator (laryngo-tracheal), topical anesthesia - Product Code CCT
|
Product | 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 |
Code Information |
Lot Number 161212 |
Recalling Firm/ Manufacturer |
Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland
|
Manufacturer Reason for Recall | Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label. |
FDA Determined Cause 2 | 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 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." |
Quantity in Commerce | 25 units |
Distribution | TX |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|