Recall Z-1628-2012 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Arcadia Medical Corporation
Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management.
| Date | May 21, 2012 (initiated Apr 18, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 01103307 (50 units) and 01107055 (73 units) |
| Distribution | Worldwide Distribution - US, including Mariemount, OH and countries of UK and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031553 | SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES Arcadia Medical Corporation, Nov 18, 2003 |