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U.S. Department of Health and Human Services

Class 2 Device Recall Portex Disc Filter

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 Class 2 Device Recall Portex Disc Filtersee related information
Date Initiated by FirmJuly 18, 2023
Date PostedAugust 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2466-2023
Recall Event ID 92614
Product Classification Filter, bacterial, breathing-circuit - Product Code CAH
ProductPORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Code Information 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
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall		Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
FDA Determined
Cause 2		Device Design
ActionSmiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 07/18/2023 by U.S. Mail. The notice explained the problem, potential risk, and requested the consignees perform the following actions: 1. Discontinue use and distribution of affected product; quarantine all product 2. Inform all users within your facility 3. If the product was further distributed, please indicate the contact information for the new owner of the product on the response form. Smiths Medical is seeking the return of the affected product.
Quantity in Commerce66,633 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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