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Recall Observatory FDA recall evidence

Device product

Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

Z-2727-2020

July 06, 2020

Class II

Product summary

Firm
TELEFLEX MEDICAL INC
Event
Event 85996
Status
Terminated
Classification
Class II
Quantity
27341 units
Official record key
device-enforcement:Z-2727-2020

Official wording

Reason: Breaking at the point of a welded joint

Code information: Lot/Batch Numbers: 1812431 1901431 1902431 1903431 1904431 1905431 1906431 1907431 1908431 1909431

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