Reported Sep 6, 2023 · Ongoing
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
PORTEX 0.5u HYDROPHOBIC DISC FILTERREF 002291 - Bacterial/Viral filter
- Lot codes and dates
- UDI/DI 30351688410645
- Lot Numbers
341999834204413429265343272234400063467682346768334753493489248349379735095693521742352624535263373529553352967235339823542040354640835649933570687357084035761293576138363506736465463658725367831436884063695958369600937088843727517372893837451003754085376438837684643784917378880437910993798345380261638062353843436384679538558643855865385848738620853864846386764038676413874801387833238810263884523389189239049373917655
- Amount recalled
- 66,633 units
Where it was sold
- Nationwide
Why it was recalled
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
This product could cause temporary or reversible health problems — stop using it.
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