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Terminated

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

FDA Recall Z-0531-2021 · Posted None

Recalling FirmVerathon, Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2020-09-29
Date Terminated2022-06-29
Product Quantity398 units

Reason for Recall

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

Firm Action

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 [email protected]. 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 [email protected]. 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 [email protected]. 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

Root Cause

Vendor change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172356BladderScan Prime PLUS SystemVerathon Incorporated · 2017-09-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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