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Lower risk Medical device recall · FDA · Published July 15, 2021

Smiths Medical Pneupac paraPac Plus 300 Ventilator Kit Recall: Duplicate Serial Numbers

Smiths Medical recalls Pneupac paraPac Plus 300 ventilator kits with duplicate serial numbers. This may cause confusion in identification and potential safety risks.

🇺🇸 FDA recall #Z-0163-2022Medical deviceSmiths Medical ›
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Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
✎ GovInfoNow plain-language explainer

What happened, in plain English

Smiths Medical is recalling Pneupac paraPac Plus 300 ventilator kits that have duplicate serial numbers. This issue could lead to confusion in identifying the correct device, which might affect patient safety. Read more at govinfonow.com/recall/62202-smiths-medical-pneupac-parapac-plus-300-ventilator-kit-recall-duplicate.

Source Summary by GovInfoNow · govinfonow.com/recall/62202-smiths-medical-pneupac-parapac-plus-300-ventilator-kit-recall-duplicate · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0163-2022

Cite this page

“Smiths Medical Pneupac paraPac Plus 300 Ventilator Kit Recall: Duplicate Serial Numbers.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62202-smiths-medical-pneupac-parapac-plus-300-ventilator-kit-recall-duplicate. Based on FDA recall #Z-0163-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0163-2022%22&limit=1).

Why it’s dangerous

Duplicate serial numbers can cause confusion when identifying the correct device. This may lead to incorrect use or mismanagement of the ventilator, potentially affecting patient safety.

Who’s affected

Healthcare providers using the Pneupac paraPac Plus 300 ventilator kit with serial number RF70121 are likely affected. Patients using this equipment may be at risk if the duplicate serial number causes identification errors.

How to tell if you have this one

Check for the serial number RF70121 on the Pneupac paraPac Plus 300 ventilator kit. The product was sold with the reference number P300NGB.

  • Brand
    Smiths Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Number

    Verify the serial number on the ventilator kit; if it is RF70121, it is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Jul 15, 202112. FDA classified it Class III: Oct 22, 202123. Published in FDA’s Enforcement Report: Nov 3, 202134. FDA terminated the recall: Aug 11, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of injury from this issue?

The recall addresses potential confusion in identification, but no specific injury risk is stated.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0163-2022 (July 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0163-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA