FDA Devices Moderate Class II Ongoing

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only

Reported: June 21, 2023 Initiated: April 22, 2023 #Z-1917-2023

Product Description

Reason for Recall

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

Details

Recalling Firm: Merit Medical Systems, Inc.
Units Affected: 17 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.
Location: South Jordan, UT

Frequently Asked Questions

What product was recalled? ▼

Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only. Recalled by Merit Medical Systems, Inc.. Units affected: 17 units.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 21, 2023. Severity: Moderate. Recall number: Z-1917-2023.