Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (10
FDA device recall Z-1486-2014 · posted 2014-04-22 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- 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
- Action taken
- Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 186
- Distribution
- Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.
- Date initiated
- 2014-04-14
- Date posted
- 2014-04-22
- Date terminated
- 2014-07-17
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERIT HYDROPHILIC GUIDE WIRE (K120644) | Merit Medical Systems, Inc. | 2012-09-19 |