FDA Device recall Z-1421-2023
(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm)
- FDA Device
- Class II
- ongoing
- Published 2023-05-03
On 2023-05-03 the FDA classified a Class II recall of (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm) by Carefusion 2200, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1421-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-16 |
| Published | 2023-05-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion 2200 |
| Distribution | 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, PR, SC, TN, TX, VA, WA, WI, WV |
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).
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.
Identifiers
| code_info | Lot number D22XBB for both products. V. Mueller Graves UDI-DI 10885403042744; V. Mueller Pederson UDI-DI 10885403042812. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1421-2023%22
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