Thermovent 1200, Heat and Moisture Exchanger Catalog # 580021
FDA device recall Z-1131-04 · posted 2004-07-22 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Sterility of the device is compromised due to lack of package integrity
- Action taken
- Smiths Medical notified Direct Customers were contacted via letter delivered by Federal Express on July 13, 2004. Dealers were contacted via letter starting on July 14, 2004.Users are requested to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- BYD
- Distribution
- Nationwide
- Date initiated
- 2004-07-13
- Date posted
- 2004-07-22
- Date terminated
- 2012-05-08
- Location
- Keene, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERMOVENT 600, 1200, T, 02 (K874597) | Portex, Inc. | 1988-01-19 |