Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm
Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.
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 the potential delay or interruption of therapy, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Hospira Inc. is recalling 357,778 units of the Plum A+3 Infusion Pump, List Number 12391. The recall is due to a defect where the fluid shield diaphragm is undersized. This issue may result in alarms or the delay or interruption of therapy.
The affected devices were distributed nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, as well as in Costa Rica, Turks and Caicos, and the Dominican Republic. The recall covers specific serial numbers listed in the agency's documentation.
Hospira is the recalling firm. The source text does not specify the corrective action consumers or healthcare facilities should take, such as whether to stop using the device or contact the manufacturer for a replacement.
The recalled product
- Product
- Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor b
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 357,778
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 (20)
- List Number 12391. Serial numbers: 13840001
- 13840002
- 13840003
- 13840004
- 13840005
- 13840006
- 13840007
- 13840008
- 13840009
- 13840010
- 13840011
- 13840012
- 13840013
- 13840014
- 13840015
- 13840016
- 13840017
- 13840018
- 13840019
- 13840020
Distribution
Part of a larger recall action
This product is one of 9 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.
See all 9 products in this recall →Related recalls
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