Z-2284-2012Class II

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid...

Name: Z-2284-2012 QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid...
Creator: Steris Corporation
Published: 2012-08-10
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2012-08-10 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor on 2012-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2284-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-10
Posted: 2012-08-28
Terminated: 2013-07-05
Recalling firm: STERIS Corporation
Product: QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Product code: MED Sterilant, Medical Devices
Reason for recall: 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..
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 64 units
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 codes and lots: Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2284-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2284-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-28

Product code MED

K090036Class IISystem 1.5 Sterile Processing SystemSTERIS Corporation / cleared 2010-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)