Medical filter barcode does not match product expiration date
Smiths Medical recalls 66,633 PORTEX 0.5u Hydrophobic Disc Filters nationwide due to a labeling error where the barcode (UDI) does not correctly reflect the product expiration date.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall where the labeling error (barcode not matching actual expiration date) could result in use of expired filters in clinical settings. No illnesses or injuries have been reported. This constitutes a risk-of-harm scenario without reported injury, meeting the High severity threshold.
Plain-English summary
Smiths Medical ASD Inc. is recalling 66,633 PORTEX 0.5u Hydrophobic Disc Filters (REF 002291), which are bacterial/viral filters distributed nationwide. The recall addresses a labeling error: the product barcode (UDI) does not correctly reflect the expiration date.
The affected product has UDI/DI 30351688410645 and includes 60 affected lot numbers. Smiths Medical identified this labeling discrepancy. Customers should verify the actual expiration date on the product packaging itself rather than relying on the barcode.
The recalled product
- Product
- PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Medical Filter
- Hazard
- expiration-date-mislabeling
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 (20)
- UDI/DI 30351688410645
- Lot Numbers: 3419998
- 3420441
- 3429265
- 3432722
- 3440006
- 3467682
- 3467683
- 3475349
- 3489248
- 3493797
- 3509569
- 3521742
- 3526245
- 3526337
- 3529553
- 3529672
- 3533982
- 3542040
- 3546408
Distribution
Distributed nationwide across the United States.
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