Hospira Recalls 1,490 Plum 360 Infusion Pumps Due to Calibration Error
Hospira is recalling 1,490 Plum 360 infusion pumps because a calibration error may cause false proximal occlusion alarms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a calibration error causing false alarms, which is a risk-of-harm product issue where specific injuries are not reported in the source text.
Plain-English summary
Hospira Inc. is recalling 1,490 units of the Plum 360 large volume infusion pump. The device is used to deliver fluids for various therapies, including parenteral, enteral, or epidural infusions. The recall affects specific units identified by list numbers 300100405, 300100406, 300100605, 300101305, 300102705, 300105405, and 300106507.
The firm's investigation determined that the issue stems from the mechanism calibration process being performed with an out-of-specification metal cassette. This error resulted in an offset in proximal pressure, leading to observed Proximal Occlusion Alarms in the field. The recall is classified as Class II by the FDA.
The affected devices were distributed nationwide in the United States and in several foreign countries, including Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, the United Kingdom, and Uruguay. Healthcare facilities should identify affected units by their list numbers and follow the recalling firm's instructions for remediation.
The recalled product
- Product
- The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more r
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 1,490
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- PLum 360 devices with the following list number: 300100405
- 300100406
- 300100605
- 300101305
- 300102705
- 300105405 and 300106507.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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