Z-1996-2021 Class II Terminated
FDA device recall Z-1996-2021 was initiated by Flowonix Medical Inc on May 26, 2021 and is designated Class II. Reason for recall: Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as '… The recall status is terminated (terminated February 20, 2024). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- May 26, 2021
- Termination Date
- February 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228 16827 Prometra II Programmable 40mLPump 00810335020242
Reason for Recall
Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection
Distribution Pattern
US Nationwide distribution.
Code Information
All Physician Order Form (PL-15400-00, Nov. 2018)