—#122874

Product

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

FDA product code: CCW — Laryngoscope, Rigid
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Product Code 004551004; Lot 1305342

Why it was recalled

Labeling inconsistency

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-10-15
Posted by FDA: 2013-11-20
Terminated: 2015-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.