Na C1140E
by Corporation Steris Canada GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00724995090784 | Date2 Jan 2020 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
-
- Terminated Z-1180-2016
The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.
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- Terminated Z-0616-2014
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.
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- Terminated Z-1596-2013
During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.
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- Terminated Z-2284-2012
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..
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- Terminated Z-2335-2012
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.
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- Terminated Z-0869-2012
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
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- Terminated Z-3124-2011
STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.
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- Terminated Z-1960-2011
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
Specification
- Trade Name
- Na
- Generic Name
- Liquid sterilant sterilizer
- Model / Ref / Catalog
- C1140E
- Description
- The Automated LCS Flexible Container and Tray is used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.
- Primary DI / UDI-DI
- 00724995090784
- 510(k) Number
- FDA Product Code
- MED
- GMDN Term
- Liquid sterilant sterilizer
- Device Class
- Class II
- Regulation Number
- 880.6885
- Commercial Distribution
- In Commercial Distribution
Other devices from Corporation Steris Canada
Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No