Class 2 Device Recall Americakn Surgical

• Date Initiated by Firm: March 31, 2016
• Create Date: May 26, 2016
• Recall Status: Terminated on October 21, 2016
• Recall Number: Z-1751-2016
• Recall Event ID: 73734
• 510(K)Number: K854713
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
• Code Information: Lot numbers: 2015/10 BK
• Recalling Firm/ Manufacturer: American Surgical Company; 45 Congress St; Salem MA 01970-5579
• Manufacturer Reason for Recall: Product packaging defective compromising sterility
• FDA Determined Cause: Packaging process control
• Action: American Surgical issued an Urgent Recall and Field Safety Notice letter dated March 31, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were provided instruction to address affected devices in their inventory. They should address this by either selecting Action A or B: Action A: Users should perform a check of the device before use and, as stated in the IFU, patties should not be used if in an open or damaged pouch. For the affected lots, special attention should be given to lower portion of the pouch where the Tyvek and clear film are sealed. Action B: Place the affected lots in quarantine and contact American Surgical Company for an RMA and replacement. All affected devices are eligible for replacement by ASC. Complete and return confirmation of actions described in Field Safety Notice. Contact:Tel: 1-800-343-0060 Option 2, Fax: 781-595-5460 Email: CustomerService@AmericanSurgical.com
• Quantity in Commerce: 33 boxes
• Distribution: Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, 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.

• 510(K) Database: 510(K)s with Product Code = GDY