Galt Medical Corporation recalls Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF

Recalled December 23, 2020 · FDA recall Z-0568-2021 · Galt Medical

Hazard

Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle. · FDA Class II

Units

9,920 catheters (updated on 03/17/2021)

Sold at

U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE

Description

Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.

Product

Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

Manufacturer(s)

Galt Medical Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →