Z-1124-2020 Class II Ongoing
FDA device recall Z-1124-2020 was initiated by Flowonix Medical Inc on December 24, 2019 and is designated Class II. Reason for recall: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of… The recall status is ongoing. Affected quantity: 1083 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- December 24, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1083 (OUS)
Product Description
Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
Reason for Recall
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
Distribution Pattern
Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.
Code Information
All units with pump firmware version 0.26 manufactured from 2012 until the present time.