Recall Z-0568-2021— Galt Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Galt Medical Corporation, initiated 2020-11-16, terminated 2022-11-07. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Galt Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-16
- Terminated
- 2022-11-07
- Firm location
- Garland, TX, United States
Product description
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Reason for recall
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.