Recall Z-1486-2014 ยท DQX Wire, Guide, Catheter
Merit Medical Systems, Inc.
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
| Date | Apr 22, 2014 (initiated Apr 14, 2014) |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3 |
| Root cause | Process control |
| Action | Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products. |
| Quantity | 186 |
| Distribution | Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120644 | MERIT HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc., Sep 19, 2012 |