Device product
LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
Z-2314-2017
Product summary
- Firm
- Cook Inc.
- Event
- Event 77167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 327 lots, 288 units
- Official record key
device-enforcement:Z-2314-2017
Official wording
Reason: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Code information: CATALOG NUMBER: and GPN: J-LSI-102500 & G16500 Dates of Manufacture: February 2012 to December 2016
Distribution pattern: Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.
Derived failure modes
-
Unknown
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.