3M Ranger Pressure Infusor Recalled for Pressure Specification Deviation
3M is recalling one Ranger Pressure Infusor, Model 145, because it produced pressure slightly below manufacturing specifications.
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. The hazard involves a deviation from manufacturing specifications (pressure slightly below spec) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
3M Company - Health Care Business is recalling one unit of the 3M Ranger Pressure Infusor, Model 145, SKU 70200792979. The device is a hardware unit intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
The recall was initiated after it was discovered that the specific unit, identified by Serial Number 100873, produced a left chamber pressure that was slightly below the manufacturing specification. The distribution for this specific unit was limited to Texas.
Consumers who possess this specific serial number should stop using the device and contact 3M for further instructions.
The recalled product
- Product
- 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
- Manufacturer
- 3M Company - Health Care Business
- Hazard
- Affected units
- 1
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 (1)
- Serial Number: 100873
Distribution
Distributed in 1 state:
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