Recall Z-0366-2014

Teleflex Medical · initiated October 15, 2013

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: Product Code 004551004; Lot 1305342

Reason for recall

Labeling inconsistency

FDA-determined cause: Other

Action taken

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.

Details

Recall number
Z-0366-2014
Initiated
October 15, 2013
Posted by FDA
November 20, 2013
Terminated
November 4, 2015
Product code
CCW – Laryngoscope, Rigid
Quantity
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.
Recalling firm
Teleflex Medical, Durham, NC

Official FDA recall record