Recall Z-1266-2016— PMBS, LLC

Name: FDA recall Z-1266-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-13

Class II · Terminated

Class II FDA medical device recall by PMBS, LLC, initiated 2016-01-13, terminated 2017-09-27. It names one FDA 510(k) clearance: K110898. Product: The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit). Reason: Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility..

Recalling firm: PMBS, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-01-13
Terminated: 2017-09-27
Firm location: Stockton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K110898 — S.C.O.R.E.S. UNITAmmed Surgical Equipment, LLC·cleared 2012-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.