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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.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Smiths Medical ASD Inc.: Portex Hydrophobic Disc Filters Recalled for Labeling and Expiration Errors

Agency Publication Date: August 28, 2023
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Summary

Smiths Medical ASD Inc. has recalled 66,633 units of the PORTEX 0.5u Hydrophobic Disc Filter, which is used as a bacterial and viral filter. The recall was initiated because the product's barcode (UDI) does not correctly reflect the actual expiration date of the filter. This labeling error means healthcare providers might unknowingly use a product that has passed its shelf life, potentially compromising its effectiveness in preventing contamination.

Risk

If an expired filter is used due to the incorrect barcode information, it may fail to provide the necessary bacterial or viral protection, potentially leading to infections or cross-contamination in medical settings.

What You Should Do

  1. Locate your PORTEX 0.5u Hydrophobic Disc Filter (REF 002291) and check the package for the identifying barcode UDI/DI 30351688410645.
  2. Verify if your product matches any of the following lot numbers: 3419998, 3420441, 3429265, 3432722, 3440006, 3467682, 3467683, 3475349, 3489248, 3493797, 3509569, 3521742, 3526245, 3526337, 3529553, 3529672, 3533982, 3542040, 3546408, 3564993, 3570687, 3570840, 3576129, 3576138, 3635067, 3646546, 3658725, 3678314, 3688406, 3695958, 3696009, 3708884, 3727517, 3728938, 3745100, 3754085, 3764388, 3768464, 3784917, 3788804, 3791099, 3798345, 3802616, 3806235, 3843436, 3846795, 3855864, 3855865, 3858487, 3862085, 3864846, 3867640, 3867641, 3874801, 3878332, 3881026, 3884523, 3891892, 3904937, or 3917655.
  3. Contact your healthcare provider or Smiths Medical ASD Inc. directly to determine if the product should be returned or replaced based on the corrected expiration data.
  4. For further information or technical questions, contact Smiths Medical at their Minneapolis office or visit their website for recall updates.
  5. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Corrective labeling or replacement verification

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

Affected Products

Product: PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Model / REF:
REF 002291
UPC Codes:
30351688410645
Lot Numbers (60):
3419998
3420441
3429265
3432722
3440006
3467682
3467683
3475349
3489248
3493797
3509569
3521742
3526245
3526337
3529553
3529672
3533982
3542040
3546408
3564993
3570687
3570840
3576129
3576138
3635067
3646546
3658725
3678314
3688406
3695958
3696009
3708884
3727517
3728938
3745100
3754085
3764388
3768464
3784917
3788804
3791099
3798345
3802616
3806235
3843436
3846795
3855864
3855865
3858487
3862085

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92614
Status: Active
Manufacturer: Smiths Medical ASD Inc.
Sold By: Direct medical distribution
Manufactured In: United States
Units Affected: 66,633 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.