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U.S. Department of Health and Human Services

Class 2 Device Recall LapSac Introducer Set

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  Class 2 Device Recall LapSac Introducer Set see related information
Date Initiated by Firm May 01, 2017
Create Date June 08, 2017
Recall Status1 Terminated 3 on March 26, 2019
Recall Number Z-2315-2017
Recall Event ID 77167
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
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.
Code Information CATALOG NUMBER and GPN: 054300 & G15771 Dates of Manufacture: January 2012 to August 2015
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Departme
812-339-2235
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 327 lots, 335 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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