FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids
- Recall number
- Z-0866-2011
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids
- Status
- Terminated
- Initiated
- 2010-11-17
- Posted
- 2011-01-07
- Terminated
- 2012-03-23
- 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 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.
- 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, and the UK
- Lot, serial or model codes
- LOT NO.: F762656, F762657, F775508, F775516, F775524, F775533, F775552. . . . H101842, H101902, H108630, H110628, H110629, H110630, H110631, H113645, H113655, H115407, H115409, H118206 ,H118207, H118208, H118209, H118210, H118211, H121450, H121780, H124502, H124506, H124507, H124508, H124509, H124510, H124511, H134990, H134991, H134992, H134993, H134994, H137477, H139171, H141155, H141162, H144090, H144098, H152489, H161044, H168461, H176238, . . . . . T119693, T121646, T122832,T124548, T130679, T132868, T132953, T133542, T134201, T135053, T137437, T139844, T140413, T140414, T141401, T141403, T141404, T142352, T143776, T146337, T146360, T149794, T150330, T150862, T151354, T153082, T153417, T153437, T153683, T153684, T153987, T154640, T157268, T160213, T162756, T167168, T167454, T167544, T168498, T171102, T171125, T171265, T173628, T173860, T174223, T176638, T176932, T177808, T178914, T179018, T179791, T181437
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- gbx
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28