Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC8, G12565.
FDA device recall Z-2083-2010 · posted 2010-07-26 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 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, a
- Date initiated
- 2010-04-21
- Date posted
- 2010-07-26
- Date terminated
- 2012-01-23
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS (K093469) | Cook, Inc. | 2010-01-08 |