Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
This recall has been terminated (originally issued April 22, 2014).
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- April 14, 2014
- Posted
- April 22, 2014
- Terminated
- July 17, 2014
- Recall Number
- Z-1486-2014
- Quantity
- 186
- Firm Location
- South Jordan, UT
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
Lot / Code Info
Lot No. K556402, Expires 2016-10
Root Cause
Process control
Action Taken
Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.