Recall Z-0588-2020 ยท KRA Catheter, Continuous Flush
Cook Inc.
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
| Date | Dec 9, 2019 (initiated Nov 8, 2019) |
| Status | Terminated |
| Reason | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides). |
| Root cause | Process control |
| Action | Urgent Medical Device Recall notification letters dated 11/8/19 were sent. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. Note: Unaffected products that are returned will not be credited. 3. Please complete the Ac |
| Quantity | 6 |
| Distribution | Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161801 | CrossCath Support Catheter Cook Incorporated, Jul 29, 2016 |