Recall Z-2106-2010 ยท DQX Wire, Guide, Catheter
Merit Medical Systems, Inc.
Merit Laureate Hydrophylic Guide Wire, Straight Stiff Shaft, Made in Ireland, CAT No: LWSTFS35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
| Date | Jun 28, 2010 |
| Status | Terminated |
| Reason | Guidewires have decreased lubricity at the proximal end, inhibiting proper operation. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 40 units |
| Distribution | Nationwide distribution: CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, NC, NH, NJ, NY, PA, and SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092303 | MERIT LAUREATE HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc., Oct 27, 2009 |