FDA recall Z-2466-2023

Smiths Medical ASD Inc. · Class II · device

Product

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-07-18
Report date
2023-09-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2466-2023