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Terminated

Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").

FDA Recall Z-1486-2014 · Posted 2014-04-22

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDQX
Date Initiated2014-04-14
Date Terminated2014-07-17
Product Quantity186

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

Firm Action

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

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120644MERIT HYDROPHILIC GUIDE WIREMerit Medical Systems, Inc. · 2012-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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