—#176306

Product

Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

FDA product code: OES — Cardiac Catheterization Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

Why it was recalled

Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: U.S.: VA, IL

Timeline

Recall initiated: 2018-10-26
Terminated: 2020-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.