Recall Z-0866-2011 ยท GBX Catheter, Irrigation
Merit Medical Systems, Inc.
Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids
| Date | Jan 7, 2011 (initiated Nov 17, 2010) |
| Status | Terminated |
| Reason | The catheter's valved hub may fail resulting in an inability to drain fluid. |
| Root cause | Device Design |
| Action | Merit Medical Systems, Inc. sent a Product Safety Notice letter dated November 18, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide a copy of the Safety Notice form to their applicable customers. Advise them to immediately stop using the affected product and to discard it. Customers were asked to complete and sign the Safety Notice forms and fax them to 1-801-208-3378 and send the original Safety Notice Form with both signatures via Federal Express 2nd day air to: Customer Service |
| Quantity | 20,863 |
| Distribution | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, AND WV and the countries of Canada, Finland, Germany, Netherlands, Singapore, Sweden, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.