Class 2 Device Recall Aspira Peritoneal Drainage Catheter Insertion Tray

• Date Initiated by Firm: April 22, 2023
• Date Posted: June 14, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1908-2023
• Recall Event ID: 92301
• 510(K)Number: K110396 K212675
• Product Classification: Peritoneal, drainage catheter for refractory ascites, long-term indwelling - Product Code PNG
• Product: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
• Code Information: Lot # I2605742; UDI-DI: 00884450398166
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: Merit Customer Service; 801-253-1600
• Manufacturer Reason for Recall: There is a potential that valve assemblies will not open. preventing fluid from draining.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 5 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PNG and Original Applicant = C.R. BARD, INC.; 510(K)s with Product Code = PNG and Original Applicant = Merit Medical Systems, Inc.