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.
Reported: June 14, 2017 Initiated: May 1, 2017 #Z-2314-2017
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 327 lots, 288 units
- Distribution
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Inc.. Units affected: 327 lots, 288 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2314-2017.
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