—#111699

Product

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

FDA product code: MED — Sterilant, Medical Devices
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090036
Affected lot / code info: Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190

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..

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-08-10
Posted by FDA: 2012-08-28
Terminated: 2013-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111699. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.