Recalls / —

—#204421

Product

Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY

FDA product code

QEY — Mechanical Thrombolysis Catheter

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K992231

Affected lot / code info

REF: IS4-135-30 Lot # H2765720 UDI: 00884450000885 REF: IS4-90-10 Lot # H2765603 UDI: 00884450006504

Why it was recalled

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Root cause (FDA determination)

Package design/selection

Action the firm took

On November 6, 2023, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via Email or UPS. Merit Medical asked consignees to take the following actions: 1. 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 response@merit.com within seven (7) 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.

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 AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.

Timeline

Recall initiated

2023-11-06

Posted by FDA

2024-01-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.