Portex 0.5u Hydrophobic Disc Filter recall: Labeling Error
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Why was Portex 0.5u Hydrophobic Disc Filter recalled?
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 30351688410645, 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, 3917655
- Product
- PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 66,633 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)