Class 2 Device Recall Carefusion V. Mueller

• Date Initiated by Firm: March 16, 2023
• Date Posted: April 21, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1421-2023
• Recall Event ID: 91722
• Product Classification: Speculum, vaginal, metal - Product Code HDF
• 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).
• Code Information: Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744; V. Mueller Pederson UDI-DI 10885403042812.
• Recalling Firm/ Manufacturer: Carefusion 2200 Inc; 75 N Fairway Dr; Vernon Hills IL 60061-1845
• For Additional Information Contact: Troy Kirkpatrick; 858-617-2361
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.