Recalls / —

—#200200

Product

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only

FDA product code

PNG — Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K110396, K212675

Affected lot / code info

Lot # I2559297, I2564678, I2553915, I2614173, I2568219; UDI-DI: 00884450394939

Why it was recalled

There is a potential that valve assemblies will not open. preventing fluid from draining.

Root cause (FDA determination)

Process control

Action the firm took

Beginning on April 22, 2023, Merit Medical issued an "Urgent Medical Device Recall Notice" to affected consignees via FedEx and UPS. On May 31, 2023, Merit Medical expanded the scope and notified additional consignees. Merit Medical 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. For Aspira Valve Replacement Kits, please immediately return all affected product in your possession to Merit, per the instructions in the attached CRF. 5. For Aspira Insertion Trays, follow the attached instructions for placing the recall labels. At the point of use, the valve assembly in the Insertion Tray is to be discarded and replaced by one of the replacement Aspira Valve Repair Kits. 6. 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. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

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 AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

Timeline

Recall initiated

2023-04-22

Posted by FDA

2023-06-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #200200. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.