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Recall Observatory FDA recall evidence

Device product

Ultracell Wick with 80cc Collection Bag, 20/box

Z-1199-2023

December 20, 2022

Class II

Product summary

Firm
Beaver Visitec International, Inc.
Event
Event 91488
Status
Ongoing
Classification
Class II
Quantity
4640 units in total
Official record key
device-enforcement:Z-1199-2023

Official wording

Reason: Device packaging may contain open seals, compromising product sterility.

Code information: Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123

Distribution pattern: US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging may contain open seals, compromising product sterility