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U.S. Department of Health and Human Services

Class 2 Device Recall American Surgical

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  Class 2 Device Recall American Surgical see related information
Date Initiated by Firm March 31, 2016
Create Date May 26, 2016
Recall Status1 Terminated 3 on October 21, 2016
Recall Number Z-1798-2016
Recall Event ID 73734
510(K)Number K902921  
Product Classification Neurosurgical paddie - Product Code HBA
Product American Surgical Uniqcot 1/2" x 2"
Ref Number: 67-29
Product Usage:
Neurosurgical and Nonneurosurgical Sponges
Code Information Lot numbers:  2015/09 BG 
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 2
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 3 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 = HBA and Original Applicant = AMERICAN SILK SUTURES, INC.
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