Class II

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

Natus Medical Incorporated · November 28, 2023

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

2,686 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0634-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Natus Medical Incorporated Medical Device Recall: External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only | SafeCheck