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U.S. Department of Health and Human Services

Class 2 Device Recall Fountain Infusion System

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  Class 2 Device Recall Fountain Infusion System see related information
Date Initiated by Firm November 06, 2023
Date Posted January 02, 2024
Recall Status1 Open3, Classified
Recall Number Z-0629-2024
Recall Event ID 93461
510(K)Number K992231  
Product Classification Mechanical thrombolysis catheter - Product Code QEY
Product Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Code Information REF: IS4-135-30 Lot # H2765720 UDI: 00884450000885 REF: IS4-90-10 Lot # H2765603 UDI: 00884450006504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Ms. Hannah Gay
801-253-1600
Manufacturer Reason
for Recall		 The sterility of microcatheter and infusion system devices cannot be guaranteed.
FDA Determined
Cause 2		 Package design/selection
Action On November 6, 2023, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via Email or UPS. Merit Medical asked consignees to take the following actions: 1. 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 Customer Response Form to Customer Service at response@merit.com within seven (7) days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF.
Quantity in Commerce 3 units
Distribution Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QEY and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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