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U.S. Department of Health and Human Services

Class 2 Device Recall Prelude IDeal" Hydrophilic Sheath Introducer

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 Class 2 Device Recall Prelude IDeal" Hydrophilic Sheath Introducersee related information
Date Initiated by FirmJanuary 27, 2025
Date PostedMarch 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1434-2025
Recall Event ID 96292
510(K)NumberK173750 
Product Classification Introducer, catheter - Product Code DYB
ProductPrelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Code Information UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
FDA Determined
Cause 2		Packaging process control
ActionOn 1/27/2025, recall notices were sent to customers asking them to do the following: 1) Quarantine, and discontinue use and distribution of affected devices. 2) Return all affected lots in your possession to the recalling firm. 3) Ensure that applicable personnel within your organization are made aware of this field action. 4) 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. Questions can be directed to Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.
Quantity in Commerce40
DistributionInternational distribution to the country of Japan.
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 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) Database510(K)s with Product Code = DYB
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