Devices

Device Recall LapSac Introducer Set

Model / Serial
CATALOG NUMBER and GPN: 054300 & G15771 Dates of Manufacture: January 2012 to August 2015
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
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.
Product Description
LapSac Introducer Set, Bag, Extraction, 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.
1 Event
- Recall of Device Recall LapSac Introducer Set

Manufacturer

Cook Inc.

Manufacturer Address
Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
Manufacturer Parent Company (2017)
Cook Group Incorporated
Source
USFDA

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