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Recall Observatory FDA recall evidence

Device product

Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

Z-2726-2020

July 06, 2020

Class II

Product summary

Firm
TELEFLEX MEDICAL INC
Event
Event 85996
Status
Terminated
Classification
Class II
Quantity
75320 units
Official record key
device-enforcement:Z-2726-2020

Official wording

Reason: Breaking at the point of a welded joint

Code information: Lot/Batch Numbers: 1811421 1812421 1901421 1904421 1905421 1906421 1907421 1908421 1909421

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