Recall Z-2284-2012
Steris Corporation · initiated August 10, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Codes / lots: Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190
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..
FDA-determined cause: Device Design
Action taken
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 Kate_Beveridge@STERIS.com or via fax at (440) 350-7082. If you have any questions, contact Director, Regulatory Affairs at 440-392-7519.
Details
- Recall number
- Z-2284-2012
- Initiated
- August 10, 2012
- Posted by FDA
- August 28, 2012
- Terminated
- July 5, 2013
- Product code
- MED – Sterilant, Medical Devices
- Quantity
- 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.
- Recalling firm
- Steris Corporation, Mentor, OH