FDA-Device2014-04-30Class II
Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
Merit Medical Systems, Inc.
Hazard
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.
Sold states
Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
Affected count
173
Manufactured in
1600 West Merit Parkway, N/A, South Jordan, UT, United States
Products
Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1485-2014Don't want to check this manually?
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