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U.S. Department of Health and Human Services

Class 2 Device Recall Hydrophylic guidewire

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 Class 2 Device Recall Hydrophylic guidewiresee related information
Date Initiated by FirmJune 28, 2010
Create DateJune 26, 2015
Recall Status1 Terminated 3 on October 19, 2010
Recall NumberZ-2102-2010
Recall Event ID 56161
510(K)NumberK092303 
Product Classification wire, guide, catheter - Product Code DQX
ProductMerit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
Code Information Lot Number K131824
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact
801-316-4932
Manufacturer Reason
for Recall		Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
FDA Determined
Cause 2		Process control
ActionThe firm, Merit Medical System, Inc., notified the Sales representatives by e-mail on June 28, 2010, and instructed them to contact all of their accounts and to advise them to discontinue use and return any unused products to Merit. A Product Recall Notice was to be completed by each facility under the direction of the rep and all activities were to be completed by July 9, 2010. Questions should be directed to Penny Goldman, Senior Product Manager at 801-208-4198 or Jackie Preece, Manager, Customer Service at 801-208-4365.
Quantity in Commerce128 units
DistributionNationwide distribution: CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, NC, NH, NJ, NY, PA, and SD.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQX
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