FDA-Device2014-04-30Class II
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
Merit Medical Systems, Inc.
Hazard
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
Sold states
Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
Affected count
186
Manufactured in
1600 West Merit Parkway, N/A, South Jordan, UT, United States
Products
Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1486-2014Don't want to check this manually?
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