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Open, Classified

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

FDA Recall Z-2466-2023 · Posted 2023-08-28

Recalling FirmSmiths Medical ASD Inc.
Recall StatusOpen, Classified
Product CodeCAH
Date Initiated2023-07-18
Product Quantity66,633 units

Reason for Recall

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

Firm Action

Smiths 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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