Hospira Recalls Plum A+3 Infusion Systems Due to Broken Pressure Sensor Pin
Hospira is recalling 214 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, which corresponds to a 'High' severity score (3) in the rubric, as it involves a risk-of-harm product where the probability of serious adverse health consequences is remote.
Plain-English summary
Hospira Inc. is recalling 214 units of the Plum A+3 Infusion System. This cassette-based multifunction infusion system is designed to deliver parenteral, enteral, or epidural infusions and is distributed nationwide in the United States, as well as in Puerto Rico, the U.S. Virgin Islands, Costa Rica, and the Dominican Republic.
The recall is due to a potential defect where the distal (occlusion) pressure sensor pin may break. This pin is part of the subsystem that measures pressure within the distal line of the administration set to indicate the presence of a full or partial distal occlusion. A broken pin can only be detected through visual inspection of the distal pressure pin.
The affected units are identified by List Number 12348 and specific serial numbers ranging from 13740156 to 13741025. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion System
- Affected units
- 214
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)
- 1) List Number 12348
- Serial Numbers: 13740156
- 13740256
- 13740266
- 13740351
- 13740380
- 13740451
- 13740508
- 13740612
- 13740632
- 13740731
- 13740732
- 13740733
- 13740734
- 13740735
- 13740736
- 13740737
- 13740738
- 13740739
- 13740740
Distribution
Part of a larger recall action
This product is one of 8 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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