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Recall Observatory FDA recall evidence

Device product

(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specula, Catalog #GL31, Medium, 4 x 7/8" (10.2 x 2.2cm).

Z-1421-2023

March 16, 2023

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 91722
Status
Ongoing
Classification
Class II
Quantity
726 units
Official record key
device-enforcement:Z-1421-2023

Official wording

Reason: A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.

Code information: Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744; V. Mueller Pederson UDI-DI 10885403042812.

Distribution pattern: Distribution was made to AL, AR, AZ, CA, CO, CT, FL, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, and WV, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Canada.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labels and laser etchings were switched