Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
FDA device recall Z-0302-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- The word PED was printed on the neckflange instead of the word NEO.
- Action taken
- Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 26
- Distribution
- Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.
- Date initiated
- 2005-02-17
- Date posted
- 2005-12-23
- Date terminated
- 2007-12-04
- Location
- Gary, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE (K914088) | Bivona Medical Technologies | 1991-10-23 |