Class 2 Device Recall Merit Medical Custom Procedure Kit

• Date Initiated by Firm: October 26, 2018
• Create Date: October 01, 2019
• Recall Status: Terminated on June 12, 2020
• Recall Number: Z-0026-2020
• Recall Event ID: 83738
• Product Classification: Angiography/angioplasty kit - Product Code OEQ
• Product: Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
• Code Information: Catalog #K12T-03688H - Lot #T1401193 and #T1419935
• FEI Number: 1721504
• 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: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
• FDA Determined Cause: Error in labeling
• Action: On 10/26/2018, Merit customer service representative placed telephone calls to consignees to inform them of the latex contained in the kits/trays. On 10/29/2018, the firm sent an "Urgent Product recall Notice" to all affected consignees via FedEx. The recall notification informed customers of the following: 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 response@merit.com within 10 business days. 5. Please immediately return all affected lots in your possession to Merit, per the instructions found in the CRF. 6. If you have any questions concerning this communication, please contact Merit Customer service at (801) 208-4381 or by email at response@merit.com.
• Quantity in Commerce: 88 Kits
• Distribution: U.S.: VA, IL
• 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.