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.
This recall has been terminated (originally issued May 21, 2012).
- Company
- Arcadia Medical Corporation
- Recall Initiated
- April 18, 2012
- Posted
- May 21, 2012
- Terminated
- August 13, 2012
- Recall Number
- Z-1628-2012
- Quantity
- 01103307 (50 units) and 01107055 (73 units)
- Firm Location
- Crown Point, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US, including Mariemount, OH and countries of UK and France.
Lot / Code Info
Lot numbers: 01103307 (50 units) and 01107055 (73 units)
Root Cause
Process control
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