Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102
FDA device recall Z-1485-2014 · posted 2014-04-22 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- 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.
- 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
- 173
- 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERIT HYDROPHILIC GUIDE WIRE (K120644) | Merit Medical Systems, Inc. | 2012-09-19 |