FDA Device recall Z-0568-2021
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
- FDA Device
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16 by Galt Medical, citing due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0568-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-16 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Galt Medical |
| Distribution | FL, GA, MA, NC, NJ, OH, PA, PR, UT |
Product
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Reason
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Identifiers
| code_info | Catalog Number: DRC-002-06 Lot Numbers/UDI Code: 20108509/(01)0084 1268 100398(17)240428(10)20108509 20139676/(01)…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0568-2021%22
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