FDA-Device2020-12-23Class II
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Galt Medical Corporation
Hazard
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Sold states
U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE
Affected count
9,920 catheters (updated on 03/17/2021)
Manufactured in
2220 Merritt Dr, N/A, Garland, TX, United States
Products
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0568-2021Don't want to check this manually?
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