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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter Introducer

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  Class 2 Device Recall Catheter Introducer see related information
Date Initiated by Firm December 14, 2017
Create Date February 22, 2018
Recall Status1 Terminated 3 on July 10, 2020
Recall Number Z-0688-2018
Recall Event ID 78961
510(K)Number K152381  K143255  
Product Classification Introducer, catheter - Product Code DYB
Product PreludeSNAP Splittable Hydrophilic and
non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
Code Information Lot Numbers: Q1176348 Q1178762 Q1194660 Q1206565 Q1201803 Q1209475 Q1213042 Q1228339 Q1234189X1 Q1234639 Q1182862 Q1190097 Q1194661 Q1197055 Q1202959 Q1213024 Q1215467 Q1234979 Q1174112 Q1197331 Q1176349 Q1213048 Q1182863 Q1228338 Q1194041 Q1206577 Q1214620 Q1184987 Q1194664 Q1213051 Q1237072 Q1213018 Q1205118 Q1175815 Q1194665 Q1197054 Q1193985 Q1193397 Q1209478 Q1228340 Q1176347 Q1204708 Q1182836 Q1170938 Q1161477 Q1185050 Q1234958 Q1176345 Q1193391 Q1228356 Q1175817 Q1194663 Q1215702 Q1228354 Q1201789 
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Merit Sales Representative
801-208-4381
Manufacturer Reason
for Recall		 Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
FDA Determined
Cause 2		 Under Investigation by firm
Action Communication to consignees began on December 14, 2017. Merit requested that consignees stop using the PreludeSNAP devices for human use, discontinue distribution, and return remaining product to Merit Medical.
Quantity in Commerce 60,945 devices
Distribution US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DYB and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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