Z-1421-2023Class II

(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm)...

Name: Z-1421-2023 (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm)...
Creator: Carefusion 2200 Inc
Published: 2023-03-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-03-16 / Open, Classified / root cause: labeling and UDI

FDA source

Carefusion 2200 Inc began a recall of (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... on 2023-03-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1421-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-16
Posted: 2023-04-21
Recalling firm: Medtronic, 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).
Product code: HDF Speculum, Vaginal, Metal
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744; V. Mueller Pederson UDI-DI 10885403042812.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1421-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1421-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-21

Product code HDF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)