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Recall Observatory FDA recall evidence

Device product

Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

Z-2730-2020

July 06, 2020

Class II

Product summary

Firm
TELEFLEX MEDICAL INC
Event
Event 85996
Status
Terminated
Classification
Class II
Quantity
301085 units
Official record key
device-enforcement:Z-2730-2020

Official wording

Reason: Breaking at the point of a welded joint

Code information: Lot/Batch Numbers: 1812331 1901331 1903331 1905331 1906331 1907331 1908331 1909331

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