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U.S. Department of Health and Human Services

Class 2 Device Recall 1 mL Medallion Syringe

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  Class 2 Device Recall 1 mL Medallion Syringe see related information
Date Initiated by Firm March 23, 2017
Create Date April 27, 2017
Recall Status1 Terminated 3 on September 26, 2017
Recall Number Z-1889-2017
Recall Event ID 76938
510(K)Number K875196  
Product Classification Syringe, piston - Product Code FMF
Product 1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
Code Information Lot Numbers: B617173, H1082598, H1082648, H1082649, H1082809, H1085511, H1085645, H1092907, H1085649, H1097018, H1085658, H1085659, H1085735, H1089234, H1089419, H1090184, H1101188, H1101443.
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Cory Marsh
801-253-1600
Manufacturer Reason
for Recall
Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Consignees began receiving notification via letter on March 23, 2017 to immediately stop using or distributing the affected lots and return them back to Merit. If there are any questions, contact Merit Customer Service at (801) 208-4381.
Quantity in Commerce 23,032 units
Distribution Nationwide and other foreign consignees. No VA/govt/military or VA consignees.
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 = FMF and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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