Z-2119-2014Class II

Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and...

Name: Z-2119-2014 Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and...
Creator: Teleflex Medical
Published: 2014-07-09
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-07-09 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid... on 2014-07-09. FDA classified it as Class II and gives the reason as "Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2119-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Posted: 2014-07-26
Terminated: 2015-11-09
Recalling firm: Teleflex Medical
Product: Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
Product code: CCW Laryngoscope, Rigid
Reason for recall: Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Teleflex Medical sent an Urgent Medical Device Recall Notification dated July 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. 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 product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 120 units
Distribution: US Distribution including the states of FL, GA, KY, MD, MS, MT, PA, SC and TX.
Product codes and lots: Product Code: 004434400, Lot number: 02A1402138

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2119-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2119-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-28

Product code CCW

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)