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U.S. Department of Health and Human Services

Class 2 Device Recall 1mL Medallion Syringes

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  Class 2 Device Recall 1mL Medallion Syringes see related information
Date Initiated by Firm February 02, 2018
Create Date August 10, 2018
Recall Status1 Terminated 3 on November 30, 2020
Recall Number Z-2742-2018
Recall Event ID 80650
510(K)Number K173601  
Product Classification Syringe, piston - Product Code FMF
Product 1mL Medallion Syringes

Are used to inject fluids into, or withdraw fluids from the body.
Code Information Catalog Number: Lot Number: K01-05526P H1258821, K01-07427 H1263015, K01-07477P H1250809 and H1242962, K01-07930P H1246733,  MSS011-DG H1246809, K02-00565C H1258361,  MSS011-LG H1246810, K02-01260B H1258575 and H1265248, MSS011-PR H1242752, MSS011-R H1242754 and H1255507, K02-01331A H1252652,  K04-00748 H1258488 and H1264381, MSS011-Y H1246811, MSS011-YP H1242927, K12-03636 H1258530, and  MSS011 H1242750, H1246807 and H1255504.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Merit Customer Service
801-208-4381
Manufacturer Reason
for Recall		 Supplier manufacturing defect with the syringe plunger tip.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On February 2, 2018 Merit Medical sent a "URGENT PRODUCT RECALL NOTICE" letter to all their consignees requesting the following actions; Actions required of you: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Please fill out, scan and email the completed CRF to Merit Customer Service at response@merit.com or fax at 801.316.4880 within 10 days. 5. Please immediately return all affected lots in your possession to Merit, per the instructions found in the CRF. If you have any questions concerning this communication, please dont hesitate to contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.
Quantity in Commerce 22,234
Distribution Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, ME, MI, MN, MO, NC, ND, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TB, TN, TX, UT, VA, WI, and WV; and countries of; Canada, Colombia, France, and Italy.
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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