Recall Z-1421-2023 ยท HDF Speculum, Vaginal, Metal
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).
| Date | Apr 21, 2023 (initiated Mar 16, 2023) |
| Status | Open, Classified |
| 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 p |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.