FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1628-2018
- Recalling firm
- Teleflex Medical Europe Ltd
- 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
- Status
- Terminated
- Initiated
- 2018-03-19
- Posted
- not on file
- Terminated
- 2019-08-27
- 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 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
- 25 units
- Distribution
- TX
- Lot, serial or model codes
- Lot Number 161212
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCT
- Firm FEI
- 3007134520
- Firm city
- Athlone
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28