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Recall Observatory FDA recall evidence

Device product

REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

Z-2076-2025

June 03, 2025

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 96961
Status
Ongoing
Classification
Class II
Quantity
63 units
Official record key
device-enforcement:Z-2076-2025

Official wording

Reason: Cather packaging may contain the incorrect French size.

Code information: Lot # NGJX2513/UDI: 00801741000294

Distribution pattern: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cather packaging may contain the incorrect French size.