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Terminated

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

FDA Recall Z-1485-2014 · Posted 2014-04-22

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDQX
Date Initiated2014-04-14
Date Terminated2014-07-17
Product Quantity173

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.

Firm Action

Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120644MERIT HYDROPHILIC GUIDE WIREMerit Medical Systems, Inc. · 2012-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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