Z-2076-2010

Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8...

Name: Z-2076-2010 Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8...
Creator: Cook, Inc.
Published: 2010-04-21
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2010-04-21 / Terminated / root cause: manufacturing process

FDA source

Cook, Inc. began a recall of Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403 on 2010-04-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2076-2010
Status: Terminated
Initiated: 2010-04-21
Posted: 2010-07-26
Terminated: 2012-01-23
Recalling firm: Cook Incorporated
Product: Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.
Product code: JOH Tube Tracheostomy And Tube Cuff
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 2353818, 2240387, 2283507, 2391559, 2272941, 2395596, 2277074, 2395598, 2251489, 2300211, 2277076, 2300213, 2304560, 2314057, 2272101, 2314055, 2330811, 2297629, 2353821, 2260715, 2255291, 2272942, 2283506, 2353819, 2395597, 2240386, 2277075, 2251488, 2254635, 2246873, 2435157, 2304561, 2314056, 2314056, 2283508, 2330810, 2297628, 2280908, 2260714, 2353820, 2413134, 2442415, 2444002, 2442416, and 2444001.

Product code JOH

K093469Class IICiaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple, Prefix C-PtbsCook, Inc. / cleared 2010-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)