Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only

FDA device recall Z-1913-2023 · posted 2023-06-14 · Open, Classified

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

PNG

Quantity affected

524 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,

Date initiated

2023-04-22

Date posted

2023-06-14

Location

South Jordan, UT

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