—#92648

Product

Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8-CA, G36038.

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K093469
Affected lot / code info: 2301522, 2281770, 2267274, 2394496, 2377271, 2292858, 2343920, 2254636, 2343918, 2272103, 2412293, 2292857, 2278725, 2281769, 2358871, 2267273, 2330813, 2382671, 2416219, 2301523, 2394497, 2377270, 2272102, 2254637, 2377269, 2343919, 2292856, 2416221, 2278726, 2358870, 2382670, 2358869, 2330812, and 2394495.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-04-21
Posted by FDA: 2010-07-26
Terminated: 2012-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92648. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.