Recall Z-0568-2021 ยท KGZ Accessories, Catheter
Galt Medical Corporation
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
| Date | Dec 14, 2020 (initiated Nov 16, 2020) |
| Status | Terminated |
| Reason | Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle. |
| Root cause | Process control |
| Action | On 11/16/2020, the firm sent an "URGENT-Medical Recall Notice" to customers to inform them that certain Lots of catheters may have a tip geometry with a thicker wall, resulting in a more obtuse tip angle. This obtuse tip angle, if present in the catheter tip, can cause increased insertion resistance through the epidermis layer of the skin. The Recalling Firm is instructing customers to: Note- An updated Customer Notification Letter was sent on 11/20/2020 via email. 1. Identify and segregate the affected lot(s) that are in their possession as well as those in the possession of their end-use |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.