—#126849

Product

Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 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. K556402, Expires 2016-10

Why it was recalled

Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3

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 #126849. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.