Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.
Hazard
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.
What You Should Do
Remedy
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.
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Products
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.
- Brand
- Cook, Inc.
- UPC
- 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.
Units Affected
28819 total, all products