Pneupac paraPac plus 300 ventilator kit recalled for duplicate serial number
Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is an FDA Class III recall involving a labeling error where two devices received identical serial numbers. No injuries or illnesses have been reported. Per the rubric, FDA Class III recalls are typically rated 1 or 2; this minor labeling error justifies a Moderate (2) rating as it creates potential for device identification confusion.
Plain-English summary
Smiths Medical ASD Inc. has recalled two units of the Pneupac paraPac plus 300 ventilator kit (REF P300NGB) that were distributed in the UK. Both devices were labeled with the same serial number, making it impossible to distinguish between the two units using serial identification alone.
This duplicate labeling creates challenges in device tracking, maintenance records, and ensuring proper identification of individual units. Healthcare facilities using this product should contact Smiths Medical ASD Inc. for instructions on addressing the duplicate serial number issue.
The recalled product
- Product
- Pneupac paraPac plus 300 ventilator kit, REF P300NGB
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 2
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)
- SN RF70121
Distribution
Distribution scope not specified by the agency.
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