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Recall Observatory FDA recall evidence

Device product

Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").

Z-1485-2014

April 14, 2014

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 68041
Status
Terminated
Classification
Class II
Quantity
173
Official record key
device-enforcement:Z-1485-2014

Official wording

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.

Code information: Lot No. K556399, Expires 2016-10

Distribution pattern: Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.