Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
FDA device recall Z-0961-05 · posted 2005-07-07 · Terminated
Recall details
- Recalling firm
- Smiths Medical International Ltd
- Reason for recall
- Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAH
- Quantity affected
- 292 units
- Distribution
- CA, NJ, PA, WV
- Date initiated
- 2005-06-07
- Date posted
- 2005-07-07
- Date terminated
- 2012-05-08
- Location
- Hythe, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEPA FILTERED HME (K930816) | Intertech Resources, Inc. | 1993-07-01 |