Verathon BladderScan Prime Plus Probe Recall for Handle Cracking Risk
Verathon is recalling 398 BladderScan Prime Plus Probes because a change in handle material and process may cause the handle to crack.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the handle may crack, but the source text does not report any injuries or illnesses.
Plain-English summary
Verathon, Inc. is recalling 398 units of the BladderScan Prime Plus Probe (REF 0570-0395). This medical device is intended to be used for measuring the urine volume in the bladder noninvasively.
The recall is being conducted because a change in the handle material and process may cause the probe handle to crack. The affected units were distributed worldwide, including nationwide distribution in the United States and in Australia, Belgium, Canada, France, Germany, Kuwait, Luxembourg, New Zealand, Portugal, Singapore, Sweden, Switzerland, Taiwan, and the United Kingdom.
Consumers and healthcare facilities should stop using the affected probes and contact Verathon, Inc. for instructions on how to proceed.
The recalled product
- Product
- BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
- Manufacturer
- Verathon, Inc.
- Hazard
- Affected units
- 398
Distribution
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