—#155145

Product

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.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: CATALOG NUMBER and GPN: 054300 & G15771 Dates of Manufacture: January 2012 to August 2015

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Cook Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 26, 2017 to its customers. Letters were mailed to customers via courier on April 28, 2017. The letter described the product, problem, and actions to be taken. The customers were instructed to: examine your inventory immediately to identify and quarantine affected products; complete and return the required Acknowledgment and Receipt form (even if you do not have affected product) via fax (812.339.7316) or email (fieldactionsna@cookmedical.com); return and discard any affected products, and Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at customerrelationsna@cookmedical.com. Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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.

Timeline

Recall initiated: 2017-05-01
Terminated: 2019-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.