—#126848

Product

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

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K120644
Affected lot / code info: Lot No. K556399, Expires 2016-10

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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

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

Timeline

Recall initiated: 2014-04-14
Posted by FDA: 2014-04-22
Terminated: 2014-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.