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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 Syringesee related information
Date Initiated by FirmMarch 23, 2017
Create DateApril 27, 2017
Recall Status1 Terminated 3 on September 26, 2017
Recall NumberZ-1889-2017
Recall Event ID 76938
510(K)NumberK875196 
Product Classification Syringe, piston - Product Code FMF
Product1 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.
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information ContactCory 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
ActionConsignees 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 Commerce23,032 units
DistributionNationwide and other foreign consignees. No VA/govt/military or VA consignees.
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 = FMF
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