The Plum A+ is a dual-line volumetric infusion system recall
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home…
Why was The Plum A+ is a dual-line volumetric infusion system recalled?
Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PLum A+ devices with the following list numbers: 12391-04-25, 12391-22-05, 12391-23-05, 12391-23-15, 12391-36-07, 12391-54-05, 12391-88-01, 12391-88-02, 12391-88-03, 12391-88-04, 12391-88-05, 20792-04-25, 20792-13-09, 20792-57-15, 20792-65-01, 20792-65-02 and 20792-88-69.
- Product
- The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home…
- Recalling firm
- Hospira Inc.
- Quantity
- 2567 Plum A+ infusion pumps.
- Distribution
- U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
- Recall date
- June 15, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)