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U.S. Department of Health and Human Services

Class 2 Device Recall S.C.O.R.E.S Units

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  Class 2 Device Recall S.C.O.R.E.S Units see related information
Date Initiated by Firm January 13, 2016
Create Date March 25, 2016
Recall Status1 Terminated 3 on September 27, 2017
Recall Number Z-1266-2016
Recall Event ID 73157
510(K)Number K110898  
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Product The S.C.O.R.E.S. Unit (self contained operating room equipment
sterilization unit)
Code Information ALL distributed S.C.O.R.E.S. units are affected.
Recalling Firm/
40 Milltown Rd
Stockton NJ 08559-1303
For Additional Information Contact Michele Mauzerall
Manufacturer Reason
for Recall
Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
FDA Determined
Cause 2
Device Design
Action On January 13, 2016 PMBS, LLC sent letters to their customers informing them of the correction. Per product's instructions for use, the SCORES cabinet is to be run for a minimun of a 4 minute sterilization cycle, followed by a 30 munites dry time followed by a 30 minutes door crack time. not all facilities generate completely dry SCORES filters following these instructions. It is imperative that the filters be checked in the Operation Room prior to useing the surgical instruments sterilised within the cabinet. If the filters are wet, do not use the contents. In the letter is a IFU addendum including instructions for running the equiptment with extended cycles. For more information please contact Ms. Michele Mauzerall, CEO at 908-300-7093.
Quantity in Commerce 58 units
Distribution FL, GA, MN, NY, OH, OR SC, and TN
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 = KCT and Original Applicant = AMMED SURGICAL EQUIPMENT, LLC