Recall Z-1421-2023— Carefusion 2200 Inc
Class II · Ongoing
Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2023-03-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Carefusion 2200 Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-16
- Firm location
- Vernon Hills, IL, United States
Product description
(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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.