Recall Z-0531-2021
Verathon, Inc. · initiated September 29, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
Codes / lots: Part Number: 0570-0395 Device Listing Number: D318438 UDI Code: 0 0879123 00649 3 Serial Numbers: 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 P1503106 P1503109 P1503110 P1503111 P1503112 P1503113 P1503114 P1503117 P1503118 P1504415 P1504427 P1504463 P1504564 P1504664 P1504754 P1504906 P1505005 P1505019 P1505119 P1505133 P1505181 P1505208 P1505479 P1505481 P1505491 P1505496 P1505506 P1505531 P1505676 P1505695 P1505696 P1505762 P1505782 P1505788 P1505845 P1505874 P1505951 P1506018 P1506066 P1506161 P1506253 P1506309 P1506332 P1506348 P1506351 P1506356 P1506363 P1506371 P1506401 P1506546 P1506558 P1506737 P1506807 P1506904 P1506921 P1507029 P1507084 P1507091 P1507124 P1507202 P1507221 P1507391…
Reason for recall
Due to a change in handle material and process, probe handle may crack.
FDA-determined cause: Vendor change control
Action taken
On 10/5/2020, the firm sent a "Field Defect Correction URGENT MEDICAL DEVICE RECALL" Notification to its U.S, Customers via FedEx informing them that due to an unauthorized manufacturing change, the probe handle's plastic may become brittle and crack. Customer are instructed to: 1. Review the information contained within this Recall Notice with all staff members who should be aware of the contents of the letter. 2. Check the list of Serial Numbers that are provided within the Recall Response Form. 3. Perform a visual inspection of the probe handle for cracks or damage. 4. Based on the visual inspection of your device(s), please do one of the following: a. Unboxing and Initial Use " If your BladderScan Prime Plus probe handle plastics have no visible cracks or damage and / or you do not wish for units to be serviced, complete the attached Recall Response Form by indicating no or 0 in the text box and return the form to Verathon by email to CSNotifications@verathon.com. Or " If your BladderScan Prime Plus probe handle plastics have visible cracks and you wish for these units to be serviced, complete attached Recall Response Form by indicating by number the count of probe handle plastics that require repair in the text box and return the form by email to CSNotifications@verathon.com. Verathon Customer Care will contact you to arrange for repair of the probe handle plastics. This replacement will be at no charge to you. b. Subsequent Use If subsequent to submitting your Recall Response Form your BladderScan Prime Plus probes develop cracks (reference Figure 1) during subsequent use and you wish for them to be serviced, please email CSNotifications@verathon.com. Verathon Customer Care will contact you to arrange for repair of the probe handle plastics. This replacement will be at no charge to you. Follow the instructions within the BladderScan Prime Plus Operations and Maintenance Manual (0900-4510 Rev. 11), and as stated below, for conduct
Details
- Recall number
- Z-0531-2021
- Initiated
- September 29, 2020
- Terminated
- June 29, 2022
- Product code
- ITX – Transducer, Ultrasonic, Diagnostic
- Quantity
- 398 units
- 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…
- Recalling firm
- Verathon, Inc., Bothell, WA