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

FDA device recall Z-0866-2011 · posted 2011-01-07 · Terminated

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

gbx

Quantity affected

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, W

Date initiated

2010-11-17

Date posted

2011-01-07

Date terminated

2012-03-23

Location

South Jordan, UT