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U.S. Department of Health and Human Services

Class 2 Device Recall Prelude Guide Sheath Roadster

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  Class 2 Device Recall Prelude Guide Sheath Roadster see related information
Date Initiated by Firm March 14, 2024
Date Posted May 20, 2024
Recall Status1 Open3, Classified
Recall Number Z-1874-2024
Recall Event ID 94304
510(K)Number K211405  
Product Classification Introducer, catheter - Product Code DYB
Product Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Code Information Lot # H2800643/ UDI: 00884450770757
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		 Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
FDA Determined
Cause 2		 Employee error
Action On March 18, 2024 Merit Medical issued a "Urgent Medical Device Recall Notice to affected consignees via E-Mail. Merit Medical asked consignees to take the following actions: 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 Customer Response Form to Customer Service at response@merit.com within 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. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Quantity in Commerce 18 units
Distribution Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
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 = DYB and Original Applicant = Merit Medical Systems, Inc.
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