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Class 2 Device Recall 1 mL Medallion Syringe |
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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
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Product Classification |
Syringe, piston - Product Code FMF
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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
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For Additional Information Contact |
Cory Marsh 801-253-1600
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = FMF and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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