Reported Apr 30, 2014 · Terminated
Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 West Merit Parkway · South Jordan, UT · 84095
Is this the product you have?
Merit Laureate Hydrophilic Guide WireCatalog No. LWSTFS35260EXStraight Tip Stiff Shaft0.035" (0.89mm)260 cm (102")
- Lot codes and dates
Lot No. K556399Expires 2016-10
- Amount recalled
- 173
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- VA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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