Natus Medical Incorporated recalls External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

Recall date

November 28, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0634-2024

FDA classification

Class II

Brand / firm

Natus Medical Incorporated

Sold / distributed

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.

Why it was recalled

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only