Recall Z-0961-05 ยท CAH Filter, Bacterial, Breathing-Circuit
Smiths Medical International Ltd
Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
| Date | Jul 7, 2005 (initiated Jun 7, 2005) |
| Status | Terminated |
| Reason | Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label |
| Root cause | Other |
| Action | Smiths Medical notified 8 accounts by letter dated June 3, 2005. Distributors are requested to contact accounts end-users (hospitals) . Users are requested to return inventory. |
| Quantity | 292 units |
| Distribution | CA, NJ, PA, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930816 | HEPA FILTERED HME Intertech Resources, Inc., Jul 1, 1993 |