Recall Z-2466-2023 ยท CAH Filter, Bacterial, Breathing-Circuit
Smiths Medical ASD Inc.
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
| Date | Aug 28, 2023 (initiated Jul 18, 2023) |
| Status | Open, Classified |
| Reason | Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product |
| Root cause | Device Design |
| 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. |
| Quantity | 66,633 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.