Qkc1692e recallZ-2284-2012 · Steris Corporation · initiated Aug 10, 2012
Class II Terminated All recalls posted in August 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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..
FDA root cause category: Device Design
What the company is doing
The firm, Steris, sent a "Voluntary Field Correction: Re-labeling of QKC1692E" letter on August 10, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter to re-label the affected QKC1692E(s) and return the completed form by September 30. 2012 to: Regulatory Affairs Specialist via [email protected] or via fax at (440) 350-7082. If you have any questions, contact Director, Regulatory Affairs at 440-392-7519.
Recall details
- Recall number
- Z-2284-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 10, 2012
- Posted by the FDA
- Aug 28, 2012
- Recalling firm
- Steris Corporation
- Quantity
- 64 units
- Product code
- MED
- FDA submissions
- K090036
- Distribution
- Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV.
Product description
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Code information (models, lots, serial numbers)
Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190
Other devices under the same FDA submission
4 devices cleared under K090036 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA Quick ConnectSteris Corporation · Sterilant, medical devices2 reports
- S40 S4000Steris Corporation · Sterilant, medical devices1 report
- SYSTEM 1E Liquid Chemical Sterilant Processing SystemCorporation Steris Canada · Sterilant, medical devices1 report
- NA Quick ConnectSteris Corporation · Sterilant, medical devices1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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