Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Reported: December 23, 2020 Initiated: November 16, 2020 #Z-0568-2021
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.
Details
- Recalling Firm
- Galt Medical Corporation
- Units Affected
- 9,920 catheters (updated on 03/17/2021)
- Distribution
- U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE
- Location
- Garland, TX
Frequently Asked Questions
What product was recalled? ▼
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16. Recalled by Galt Medical Corporation. Units affected: 9,920 catheters (updated on 03/17/2021).
Why was this product recalled? ▼
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2020. Severity: Moderate. Recall number: Z-0568-2021.
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