Class 2 Device Recall COBRAOS, custom Sheath Introducer Kit

• Date Initiated by Firm: March 21, 2023
• Date Posted: May 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1578-2023
• Recall Event ID: 92042
• 510(K)Number: K070159
• Product Classification: Introducer, catheter - Product Code DYB
• Product: COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
• Code Information: Lot # H2122096S1; UDI-DI: (00)884450525197
• FEI Number: 1721504
• 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: Custom sheath Introducer contains incorrect needle size
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: On March 21, 2023 MeritMedical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. In addition to informing them about the recall, MeritMedical 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 OEMorder@merit.com within seven (7) calendar 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. If you have any questions concerning this communication, please don t hesitate to contact your Merit OEM Sales Representative or Merit OEM Customer Service at (800)-637-4839| Hours: 8 am to 5 pm MST | Mon-Fri.
• Quantity in Commerce: 1186 units
• Distribution: US Distribution to state of: Minnesota
• 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