Medical device recalls Moderate risk

Verathon, Inc. recalls BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the b…

Recall date
September 29, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0531-2021
FDA classification
Class II
Brand / firm
Verathon, Inc.
Sold / distributed
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV and WY. The countries of Austrailia, Belgium, Canada, France, Germany,…

Why it was recalled

Due to a change in handle material and process, probe handle may crack.

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

What was recalled

BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.

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