Recall Z-1485-2014 ยท DQX Wire, Guide, Catheter
Merit Medical Systems, Inc.
Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
| Date | Apr 22, 2014 (initiated Apr 14, 2014) |
| Status | Terminated |
| Reason | Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling. |
| 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 | 173 |
| 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 |