Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- June 28, 2010
- Terminated
- October 19, 2010
- Recall Number
- Z-2101-2010
- Quantity
- 437 units
- Firm Location
- South Jordan, UT
Reason for Recall
Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
Distribution
Nationwide distribution: CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, NC, NH, NJ, NY, PA, and SD.
Lot / Code Info
Lot Number K131823
Root Cause
Process control
Action Taken
The firm, Merit Medical System, Inc., notified the Sales representatives by e-mail on June 28, 2010, and instructed them to contact all of their accounts and to advise them to discontinue use and return any unused products to Merit. A Product Recall Notice was to be completed by each facility under the direction of the rep and all activities were to be completed by July 9, 2010. Questions should be directed to Penny Goldman, Senior Product Manager at 801-208-4198 or Jackie Preece, Manager, Customer Service at 801-208-4365.
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