FDA recall Z-0531-2021

Product

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.

Distribution

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, Kuwait, Luxembourg, New Zealand, Portugal, Singapore, Sweden, Switzerland, Taiwan, and United Kingdom.

Key facts

Status

Terminated

Initiation date

2020-09-29

Report date

2020-12-09

Termination date

2022-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2021