Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable In
Summary
The FDA issued a Class II for Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with by Flowonix Medical Inc. Reason: Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medicatio.
Details
Source
Device Recall
External ID
Z-1996-2021
Action Date
2021-07-07
Status
Terminated
Category
device
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
Lot/Code Info: All Physician Order Form (PL-15400-00, Nov. 2018)
Quantity Affected: N/A
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
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-26
Company
Mansfield, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Flowonix Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Flowonix Medical Inc have FDA actions?
This is the only FDA action we have on record for Flowonix Medical Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1996-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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