Reported Dec 9, 2020 · Terminated

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

Verathon, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Verathon, Inc. · 20001 N Creek Pkwy · Bothell, WA · 98011-8218

Is this the product you have?

  • BladderScan Prime Plus
  • Probe REF 0570-0395 - Product Usageintended to be used for measuring the urine volume in the bladder noninvasively
Lot codes and dates
  • Part Number0570-0395
  • Device Listing NumberD318438
  • UDI Code0 0879123 00649 3
  • Serial Numbers

    273 of 273 codes

    • P1001848
    • P1500333
    • P1500436
    • P1500486
    • P1500517
    • P1500519
    • P1500528
    • P1500604
    • P1500642
    • P1500657
    • P1501000
    • P1501088
    • P1501102
    • P1501115
    • P1501122
    • P1501247
    • P1501255
    • P1501259
    • P1501326
    • P1501330
    • P1501394
    • P1501399
    • P1501607
    • P1501625
    • P1501739
    • P1501765
    • P1501779
    • P1501788
    • P1501845
    • P1501911
    • P1501979
    • P1502058
    • P1503069
    • P1503070
    • P1503071
    • P1503072
    • P1503073
    • P1503074
    • P1503075
    • P1503076
    • P1503077
    • P1503078
    • P1503079
    • P1503080
    • P1503081
    • P1503082
    • P1503083
    • P1503084
    • P1503085
    • P1503086
    • P1503087
    • P1503088
    • P1503089
    • P1503093
    • P1503096
    • P1503098
    • P1503099
    • P1503100
    • P1503102
    • P1503104
Amount recalled
398 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 29, 2022 · Data as of Sep 19, 7:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.