Cook Medical Recalls LapSac Introducers Due to Inadequate Reprocessing Instructions
Cook Medical is voluntarily recalling LapSac Introducers because the reprocessing instructions do not provide sufficient detailed information for cleaning, disinfection, and sterilization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary measure addressing a documentation issue (insufficient reprocessing instructions) without reported injuries or illnesses, fitting the criteria for a Moderate severity score.
Plain-English summary
Cook Medical is initiating a voluntary recall of LapSac Introducers. These devices are supplied sterilized by ethylene oxide gas in peel-open packages and are used to aid in the introduction of a LapSac during endoscopic surgical procedures.
The recall is being conducted because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. The affected units include 327 lots and 288 units, with dates of manufacture ranging from February 2012 to December 2016.
The products were distributed worldwide, including nationwide in the United States and in countries such as 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. Users should contact Cook Medical for further instructions regarding the return or replacement of these devices.
The recalled product
- 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.
- Manufacturer
- Cook Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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