The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
FDA Recall Z-1266-2016 · Posted None
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Recalling FirmPMBS, LLC
Recall StatusTerminated
Product CodeKCT
Date Initiated2016-01-13
Date Terminated2017-09-27
Product Quantity58 units
Reason for Recall
Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Firm 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.
Root Cause
Device Design
Distribution Pattern
FL, GA, MN, NY, OH, OR SC, and TN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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