FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC6, G13166.
- Recall number
- Z-2080-2010
- Recalling firm
- Cook, Inc.
- Product
- Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC6, G13166.
- Status
- Terminated
- Initiated
- 2010-04-21
- Posted
- 2010-07-26
- Terminated
- 2012-01-23
- 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.
- Lot, serial or model codes
- 2451349, 2328599, 2455952, 2330814, 2336324, 2260563, 2320508, 2242064, 2289456, 2330816, 2301524, 2260561, 2393721, 2305091, 2316113, 2305089, 2417210, 2313166, 2343922, 2289454, 2301526, 2377273, 2336320, 2440350, 2236964, 2443067, 2328597, 2316115, 2298767, 2354683, 2285639, 2254641, 2280164, 2305087, 2336322, 2440352, 2236966, 2229876, 2364739, 2316117, 2285637, 2373622, 2280166, 2254638, 2316118, 2359778, 2382675, 2310206, 2343924, 2348175, 2451351, 2272949, 2328600, 2364737, 2298768, 2320506, 2354685, 2268131, 2272946, 2348177, 2310204, 2247510, 2247509, 2364740, 2242063, 2451347, 2447611, 2373624, 2268133, 2377274, 2247512, 2242061, 2455951, 2289453, 2348178, 2330815, 2359776, 2382673, 2447613, 2451348, 2328598, 2455953, 2330817, 2301525, 2298770, 2417209, 2313168, 2260562, 2320509, 2242065, 2305088, 2343923, 2417211, 2301527, 2377272, 2336321, 2260560, 2305090, 2359780, 2316114, 2354682, 2285638, 2280165, 2313167, 2343921, 2289455, 2336323, 2440351, 2236965, 2316116, 2285636, 2254640, 2280167, 2373623, 2313165, 2260564, 2364738, 2359779, 2373621, 2382674, 2447614, 2254642, 2343925, 2451350, 2254639, 2328601, 2272948, 2455954, 2409902, 2354684, 2280168, 2440349, 2268130, 2247511, 2247508, 2236963, 2242062, 2298769, 2461159, 2320507, 2268132, 2272947, 2348176, 2310205, 2285640, 2364741, 2320505, 2289452, 2348179, 2359777, 2268134, 2382672, 2447612, 2377275, 2310203, 2272945, 2443068, 2443070, and 2443069.
- 510(k) numbers
- ["K093469"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28