Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids
Recall
- Recall Number
- Z-0866-2011
- Event Number
- 57418
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 1721504
- Product Code
- gbx
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 17, 2010
- Posted
- January 7, 2011
- Terminated
- March 23, 2012
- Address
- 1600 West Merit Parkway, South Jordan, UT, 84095
Description
Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids
The catheter's valved hub may fail resulting in an inability to drain fluid.
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 Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095-2416 entirety and faxed them For questions regarding this recall call 801-316-4929 or Customer Service at 801-208-4365.
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, and the UK
20,863