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U.S. Department of Health and Human Services

Class 2 Device Recall Merit One Step Centesis Drainage Catheter

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  Class 2 Device Recall Merit One Step Centesis Drainage Catheter see related information
Date Initiated by Firm November 17, 2010
Date Posted January 07, 2011
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-0866-2011
Recall Event ID 57418
Product Classification Catheter, irrigation - Product Code gbx
Product Merit One Step Centesis Drainage Catheter
Intended for the percutaneous drainage of fluids
Code Information 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
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact Jackie Preece
801-253-1600
Manufacturer Reason
for Recall		 The catheter's valved hub may fail resulting in an inability to drain fluid.
FDA Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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