PMBS, LLC: The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

Recall number

Z-1266-2016

Recalling firm

PMBS, LLC

Product

The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

Status

Terminated

Initiated

2016-01-13

Posted

not on file

Terminated

2017-09-27

Reason

Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.

Root cause

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

58 units

Distribution

FL, GA, MN, NY, OH, OR SC, and TN

Lot, serial or model codes

ALL distributed S.C.O.R.E.S. units are affected.

510(k) numbers

["K110898"]

PMA numbers

not on file

Product code

KCT

Firm FEI

3012085539

Firm city

Stockton

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy