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Recall Observatory FDA recall evidence

Device product

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

Z-0366-2014

October 15, 2013

Class II

Product summary

Firm
Teleflex Medical
Event
Event 66640
Status
Terminated
Classification
Class II
Quantity
6,200 ea.
Official record key
device-enforcement:Z-0366-2014

Official wording

Reason: Labeling inconsistency

Code information: Product Code 004551004; Lot 1305342

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling inconsistency