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Recall Observatory FDA recall evidence

Device product

Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

Z-2731-2020

July 06, 2020

Class II

Product summary

Firm
TELEFLEX MEDICAL INC
Event
Event 85996
Status
Terminated
Classification
Class II
Quantity
350779 units
Official record key
device-enforcement:Z-2731-2020

Official wording

Reason: Breaking at the point of a welded joint

Code information: Lot/Batch Numbers: 1811341 1901341 1902341 1904341 1905341 1906341 1907341 1908341 1909341

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