Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Critical RiskFDA Device
Medical Devices

Smiths Medical ASD Inc.: paraPAC Plus 300 and 310 Ventilators Recalled for Connector Detachment

Agency Publication Date: September 20, 2024
Share:
Sign in to monitor this recall

Summary

This recall affects 14,426 Smiths Medical paraPAC Plus P300 and P310 ventilator kits, which are used to provide breathing assistance to patients. The patient outlet connector on these devices can loosen or detach, which may cause the ventilator to stop providing active ventilation. Consumers and healthcare providers should contact the manufacturer immediately for guidance on managing affected units.

Risk

If the patient outlet connector detaches during use, the device will fail to provide the necessary mechanical ventilation to the patient. This loss of breathing support can lead to severe injury, oxygen deprivation, or death, particularly for patients who are fully dependent on a ventilator.

What You Should Do

  1. Check the item number and serial number on your paraPAC Plus ventilator to see if it is included in this recall. Affected models include the paraPAC plus 310 (Item Number P310N) and the paraPAC 300 (Item Number P300N).
  2. For the paraPAC plus 310 (Item P310N), look for serial numbers ranging from 70 to 258, and various seven-digit numbers starting with 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23.
  3. For the paraPAC 300 (Item P300N), check for serial numbers 1 through 304, as well as alphanumeric codes starting with 'GC', 'GL', and 'RF'.
  4. If your device is affected, monitor it closely for any signs of the outlet connector loosening and contact your healthcare provider or Smiths Medical immediately.
  5. Reach out to Smiths Medical ASD Inc. to discuss corrective actions, further instructions, and information regarding a potential remedy or repair for the detached connector issue.
  6. For additional questions or to report a problem with the device, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/instruction letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: paraPAC plus 310 ventilator kit with internal PEEP and CPAP
Model / REF:
P310N
Lot Numbers:
Serial Numbers: 70 through 258
Serial Numbers: 1002250 through 2308005
Serial Numbers: 12312188 through 22031717
Serial Numbers: 1602162A
Serial Numbers: 530A1167
Serial Numbers: SD1054
Product: paraPAC 300 ventilator kit without internal PEEP and CPAP
Model / REF:
P300N
Lot Numbers:
Serial Numbers: 1 through 304
Serial Numbers: 70085 through 70299
Serial Numbers: 1007188 through 2308010
Serial Numbers: GC00001 through GC00250
Serial Numbers: GL10006 through GL10493
Serial Numbers: RF70003 through RF70298
Serial Numbers: 1605167A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94974
Status: Active
Manufacturer: Smiths Medical ASD Inc.
Sold By: Medical device distributors; Healthcare facilities; Hospitals
Manufactured In: United States
Units Affected: 2 products (11244 units; 3182 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.