FDA Medical Device Recalls (openFDA)
Carefusion 2200 Inc: (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 number
- Z-1421-2023
- Recalling firm
- Carefusion 2200 Inc
- 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).
- Status
- Open, Classified
- Initiated
- 2023-03-16
- Posted
- 2023-04-21
- Terminated
- not on file
- 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.
- Root cause
- Labeling mix-ups
- Action
- 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.
- Quantity
- 726 units
- 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.
- Lot, serial or model codes
- Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744; V. Mueller Pederson UDI-DI 10885403042812.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HDF
- Firm FEI
- 3008002452
- Firm city
- Vernon Hills
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28