510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0366-2014Class II

Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement...

Teleflex Medical / initiated 2013-10-15 / Terminated / root cause: labeling and UDI

Teleflex Medical began a recall of Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube on . FDA classified it as Class II and gives the reason as "Labeling inconsistency". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0366-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
Product
Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
Product code
CCW Laryngoscope, Rigid
Reason for recall
Labeling inconsistency
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Recall letters were sent to customers and distributors on 10/15/2013 via courier. The letter indicated that the consignee was to immediately discontinue use and quarantine any products with the affected catalog numbers. The letter also included a Recall Acknowledgment Form which was to be faxed back to the firm.
Quantity in commerce
6,200 ea.
Distribution
Nationwide distribution: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WI.
Product codes and lots
Product Code 004551004; Lot 1305342

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0366-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0366-2014Class IITerminatedVoluntary: Firm initiated