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/ Manufacturer |
PMBS, LLC 40 Milltown Rd Stockton NJ 08559-1303
|
For Additional Information Contact | Michele 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 |
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 |
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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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510(K) Database | 510(K)s with Product Code = KCT
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