Skip to content

V. Mueller recallZ-1421-2023 · Carefusion 2200 Inc · initiated Mar 16, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Carefusion 2200 Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

The recalling firm issued two different letters dated 3/16/2023 via FedEx 2-day and email, one to distributors and one to other consignees that were for the attention of Medical Director, Risk Manager, Medical Device Safety Officer, Lab Manager, Clinical Engineering, etc. (medical facilities). The letter to the medical facilities explained the issue, provided drawings of the two different catalog numbers and included a photograph of one of the products, provided the clinical impact, and provided the actions to be taken. These actions were to check their inventory locations for the affected product, which may continue to be used according to its true size as provided in the letter. If the facility is not able to use the affected product, the consignee is to indicate the quantity on the Customer Response Form and confirm this inventory was destroyed. The notification is to be shared with all users of the affected product within the consignee's facility network to ensure they are also aware of this product correction. The response form is to be returned via email or FAX. The distributor letter provides the same information for the actions as the other letter. They are to destroy all affected product remaining in their possession and identify all customers within their distribution network that purchased any affected product and provide them a copy of the customer letter. A Distributor Response Form was attached to indicate they do not have any of the affected product, or they do have the product, list the the quantity, and confirm that it was destroyed.

Recall details

Recall number
Z-1421-2023
Status
Open, Classified
Initiated by the company
Mar 16, 2023
Posted by the FDA
Apr 21, 2023
Recalling firm
Carefusion 2200 Inc
Quantity
726 units
Product code
HDF
Distribution
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.

Product description

(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).

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page