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Recall Observatory FDA recall evidence

Device product

Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

Z-2732-2020

July 06, 2020

Class II

Product summary

Firm
TELEFLEX MEDICAL INC
Event
Event 85996
Status
Terminated
Classification
Class II
Quantity
29740 units
Official record key
device-enforcement:Z-2732-2020

Official wording

Reason: Breaking at the point of a welded joint

Code information: Lot/Batch Numbers: 1811351 1812351 1901351 1903351 1904351 1905351 1906351 1907351 1908351 1909351

Distribution pattern: US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Breaking at the point of a welded joint