Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids

FDA Recall Z-0866-2011 · Posted 2011-01-07

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product Codegbx
Date Initiated2010-11-17
Date Terminated2012-03-23
Product Quantity20,863

Reason for Recall

The catheter's valved hub may fail resulting in an inability to drain fluid.

Firm 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 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑