Recall Z-1485-2014— Merit Medical Systems, Inc.

Name: FDA recall Z-1485-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-14

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2014-04-14, terminated 2014-07-17. It names one FDA 510(k) clearance: K120644. Product: Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").. 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..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Terminated: 2014-07-17
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K120644 — MERIT HYDROPHILIC GUIDE WIREMerit Medical Systems, Inc.·cleared 2012-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.