Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- April 14, 2014
- Posted
- April 22, 2014
- Terminated
- July 17, 2014
- Recall Number
- Z-1485-2014
- Quantity
- 173
- Firm Location
- South Jordan, UT
Reason for Recall
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.
Distribution
Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
Lot / Code Info
Lot No. K556399, Expires 2016-10
Root Cause
Process control
Action Taken
Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.
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