Hospira Recalls Plum A+ Infusion Systems with Cracked Pole Clamp Assemblies
Hospira Inc. is recalling 102 Plum A+ Infusion Systems because cracked pole clamp assemblies prevent the devices from securely attaching to IV poles.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a mechanical defect (cracked clamp) that prevents device attachment rather than causing direct patient injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Hospira Inc. is recalling 102 units of the Plum A+ Infusion System, specifically those equipped with Hospira MedNet List 20792-04-25 and Pole Clamp Assembly Part Number 820-95443-008. The recall affects devices distributed in New York, United States.
The recall was initiated because the pole clamp assemblies were discovered to be cracked. The knob on the pole clamp assembly is used to tighten and loosen the grip to secure the infuser to an IV pole. If the knob is cracked, the infuser cannot be attached to the IV pole.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If a device is found with a cracked pole clamp assembly, it should be removed from service and returned to Hospira Inc. for evaluation or replacement.
The recalled product
- Product
- Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's…
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 102
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: 20792-04-25
- Serial Numbers: 17737372
- 17737375
- 17737377
- 17737378
- 17737383
- 17737385
- 17737390
- 17737394
- 17737395
- 17737396
- 17737397
- 17737398
- 17737399
- 17737400
- 17737402
- 17737405
- 17737408
- 17737409
- 17737414
Distribution
Distributed in 1 state:
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