Cook Inc.: Medical Device Recall in 2017 - (Recall #: Z-2315-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 1, 2017

Date Posted: June 14, 2017

Recall Number: Z-2315-2017

Event ID: 77167

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.

Status: Terminated

Product Quantity: 327 lots, 335 units

Code Information:

CATALOG NUMBER and GPN: 054300 & G15771 Dates of Manufacture: January 2012 to August 2015

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.

Voluntary or Mandated:

Voluntary: Firm initiated