• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall S.C.O.R.E.S Unitssee related information
Date Initiated by FirmJanuary 13, 2016
Create DateMarch 25, 2016
Recall Status1 Terminated 3 on September 27, 2017
Recall NumberZ-1266-2016
Recall Event ID 73157
510(K)NumberK110898 
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
ProductThe 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/
Manufacturer
PMBS, LLC
40 Milltown Rd
Stockton NJ 08559-1303
For Additional Information ContactMichele Mauzerall
908-300-7093
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
ActionOn 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 Commerce58 units
DistributionFL, GA, MN, NY, OH, OR SC, and TN
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KCT
-
-