Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845 (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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845
Lot Codes / Batch Numbers
Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744, V. Mueller Pederson UDI-DI 10885403042812.
Products Sold
Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744; V. Mueller Pederson UDI-DI 10885403042812.
Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845 is recalling (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3 due to A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, VA, WA, WV, WI, PR
Page updated: Jan 10, 2026