Recalls / —

—#209789

Product

Custom Procedure Kit, REF: K12T-11077

FDA product code

OEQ — Angiography/Angioplasty Kit

Device class

Class 2

Medical specialty

Cardiovascular

Affected lot / code info

REF/UDI-DI/Lot (Expiration Date): K12T-11077/00884450457863/T2908313 (01-DEC-2024)

Why it was recalled

7F sheath introducers labeled as 7.5F

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

On 8/12/24, recall notices were mailed or emailed to customers who were asked to do the following: 1) Determine if any of the products identified in the attached Customer Response From (CRF) are within your facility. 2) Ensure that appropriate 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, ensure this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4) Post this "URGENT MEDICAL DEVICE RECALL NOTICE" on or near the affected products. Product may continue to be used once this recall notice is placed on or near them. 5) Complete and return the response form via email to response@merit.com If you have any questions concerning this communication, contact the firm's Sales Representative or Customer Service at +1 800 356 3748 | Hours: 6 am to 6 pm MST, Mon-Fri.

Recalling firm

Firm

Merit Medical Systems, Inc.

Address

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

Distribution

Distribution pattern

Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.

Timeline

Recall initiated

2024-08-12

Posted by FDA

2024-09-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #209789. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.