PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
FDA device recall Z-2466-2023 · posted 2023-08-28 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
- Action taken
- 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
- Status
- Open, Classified
- Product code
- CAH
- Quantity affected
- 66,633 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-07-18
- Date posted
- 2023-08-28
- Location
- Minneapolis, MN
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