FDAFDA · Food and drugs·Recall number Z-2284-2012
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Published September 5, 2012 · Recall initiated: August 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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..
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Steris Corporation
- Distributor
- 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.
- Lot
- Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.