Recalls / —

—#199456

Product

COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units

FDA product code

DYB — Introducer, Catheter

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K070159

Affected lot / code info

Lot # H2122096S1; UDI-DI: (00)884450525197

Why it was recalled

Custom sheath Introducer contains incorrect needle size

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm

Merit Medical Systems, Inc.

Address

1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern

US Distribution to state of: Minnesota

Timeline

Recall initiated

2023-03-21

Posted by FDA

2023-05-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #199456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.