Device product

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

Z-0568-2021

November 16, 2020

Class II

Product summary

Firm: Galt Medical Corporation
Event: Event 86795
Status: Terminated
Classification: Class II
Quantity: 9,920 catheters (updated on 03/17/2021)
Official record key: device-enforcement:Z-0568-2021

Official wording

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

Code information: Catalog Number: DRC-002-06 Lot Numbers/UDI Code: 20108509/(01)0084 1268 100398(17)240428(10)20108509 20139676/(01)0084 1268 100398(11)200520(17)240519(10)20139676 20148911/(01)0084 1268 100398(11)200609(17)240608(10)20148911 20160253/(01)0084 1268 100398(11)200707(17)240706(10)20160253 20189100/(01)0084 1268 100398(11)200821(17)240820(10)20189100 Updated Information provided 03/16/2021: For Catalog Number: DRC-002-06 additional Lot Numbers: -20080351 -20234573 -20297230 -21008452 Additional Products: Catalog Number: DRC-006-16 Lot Numbers: -20217235 -20217236 -20217237

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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