Z-1628-2018Class II

Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for...

Name: Z-1628-2018 Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for...
Creator: Teleflex Medical Europe Ltd
Published: 2018-03-19
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2018-03-19 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical Europe Ltd began a recall of Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the... on 2018-03-19. FDA classified it as Class II and gives the reason as "Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1628-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-19
Posted: 2018-05-23
Terminated: 2019-08-27
Recalling firm: Teleflex Medical
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
Product code: CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
Reason for recall: Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected]. This will allow us to document your receipt of this letter."
Quantity in commerce: 25 units
Distribution: TX
Product codes and lots: Lot Number 161212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1628-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1628-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-03

Product code CCT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)