System 1.5 Sterile Processing System

• • Terminated Z-0616-2014 FDA Class II ·initiated 21 Nov 2013 ·on shared 510(k) K090036

  Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.

• • Terminated Z-2284-2012 FDA Class II ·initiated 10 Aug 2012

  STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..

• • Terminated Z-2335-2012 FDA Class II ·initiated 1 Aug 2012

  The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.

• • Terminated Z-0869-2012 FDA Unclassified (pre-2012) ·initiated 7 Dec 2011

  Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteriae may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which

• • Terminated Z-3124-2011 FDA Unclassified (pre-2012) ·initiated 11 Aug 2011 ·on shared 510(k) K090036

  STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.

• • Terminated Z-1960-2011 FDA Unclassified (pre-2012) ·initiated 14 Mar 2011

  The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to inco

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 5 Apr 2010 Cleared FDA 510(k) K090036
2. 14 Mar 2011 Recall initiated FDA recalls Z-1960-2011
3. 11 Aug 2011 Recall initiated FDA recalls Z-3124-2011
4. 7 Dec 2011 Recall initiated FDA recalls Z-0869-2012
5. 1 Aug 2012 Recall initiated FDA recalls Z-2335-2012
6. 10 Aug 2012 Recall initiated FDA recalls Z-2284-2012
7. 21 Nov 2013 Recall initiated FDA recalls Z-0616-2014

510(k) Number

K090036 ↗

FDA product code

MED

Device class

Class II

Regulation

21 CFR Part 880.6885

Advisory committee

General Hospital

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code MED (Sterilant, Medical Devices).

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• Sterilox Liquid Chemical Sterilant System by Puricore, Inc.
• WAVICIDE(R) -01 by Wave Energy Systems, Inc.

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• Snowden-Pencer 886118V

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  GUDID on market

• Snowden-Pencer 886127V

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  GUDID on market

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