Recall Z-2466-2023— Smiths Medical ASD Inc.

Name: FDA recall Z-2466-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-18

Class II · Ongoing

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2023-07-18. FDA's recall record names no specific 510(k) clearance for this event. Product: PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter. Reason: Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product.

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-18
Firm location: Minneapolis, MN, United States

Product description

PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

Reason for recall

Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product

Data sourced from openFDA. This site is unofficial and independent of the FDA.