Recall Z-0531-2021— Verathon, Inc.

Name: FDA recall Z-0531-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-29

Class II · Terminated

Class II FDA medical device recall by Verathon, Inc., initiated 2020-09-29, terminated 2022-06-29. It names one FDA 510(k) clearance: K172356. Product: BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.. Reason: Due to a change in handle material and process, probe handle may crack..

Recalling firm: Verathon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-09-29
Terminated: 2022-06-29
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K172356 — BladderScan Prime PLUS SystemVerathon Incorporated·cleared 2017-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.