Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. C
FDA device recall Z-1628-2012 · posted 2012-05-21 · Terminated
Recall details
- Recalling firm
- Arcadia Medical Corporation
- Reason for recall
- A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
- Action taken
- Arcadia notified the 3 consignees with a MEDICAL DEVICE VOLUNTARY RECALL notification dated 4/18/12. The notification identified the affected product, along with the reason for the recall. Consignees were instructed to cease distribution/use of any unopened product that they have remaining and return to firm following the steps provided. Arcadia will replace the product at no charge to the customer. Consignees were to confirm receipt of the recall notification by emailing Trena Depel, trena@arcadiamedical.com. Phone: 925-918-0595 Fax: (415) 762-5489
- Root cause
- Process control
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 01103307 (50 units) and 01107055 (73 units)
- Distribution
- Worldwide Distribution - US, including Mariemount, OH and countries of UK and France.
- Date initiated
- 2012-04-18
- Date posted
- 2012-05-21
- Date terminated
- 2012-08-13
- Location
- Crown Point, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES (K031553) | Arcadia Medical Corporation | 2003-11-18 |