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U.S. Department of Health and Human Services

Class 2 Device Recall Prelude SNAP splittable Sheath Introducer

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  Class 2 Device Recall Prelude SNAP splittable Sheath Introducer see related information
Date Initiated by Firm June 30, 2021
Create Date August 10, 2021
Recall Status1 Terminated 3 on February 24, 2023
Recall Number Z-2239-2021
Recall Event ID 88315
510(K)Number K143255  
Product Classification Introducer, catheter - Product Code DYB
Product Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Code Information Lot # I2059849
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Mr. Cory Marsh
801-316-3690
Manufacturer Reason
for Recall		 There is a potential that 7F sheaths are packaged as 10F sheaths.
FDA Determined
Cause 2		 Packaging process control
Action On June 30, 2021, Merit Medical issued an "Urgent Medical Device Recall Notice" to affected consignees via FedEx overnight. In addition, to informing consignees about the recall, the firm ask consignees to take the following action: 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 Merit Customer Service at response@merit.com within 10 business 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 events experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch or by phone at 1-800-332-1088. 7. 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 | Hours: 6 am to 6 pm MDT | Mon-Fri.
Quantity in Commerce 760 UNITS
Distribution US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway
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 = DYB and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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