Recall Z-2092-2010 ยท JOH Tube Tracheostomy And Tube Cuff
Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51972, C-PTBSYJC-2800-PERC8.
| Date | Jul 26, 2010 (initiated Apr 21, 2010) |
| Status | Terminated |
| Reason | These set and/or tray products are being recalled because they include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheostomy tube component that has been associated with cuff leakage as a result of the pilot balloon inflation assembly. |
| Root cause | Nonconforming Material/Component |
| Action | Cook Medical sent an Urgent Product Recall letter dated April 21, 2010, to hospitals and other user facilities receiving product direct from Cook as well as distribution centers receiving direct shipments from Cook. Consignees were directed to cease distribution of product and notify their customers immediately. |
| Quantity | 28819 total, all products |
| Distribution | Worldwide distribution: USA, Canada, Mexico, Australia, Chile, Costa Rica, Denmark, Dominican Republic, Guatemala, India, Malaysia, Panama, Peru, Puerto Rico, Republic of Korea, Trinidad and Tobago, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093469 | CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS Cook, Inc., Jan 8, 2010 |