The Recall Desk
ModerateFDA (Devices)·Z-2284-2012·Announced 2012-09-05

Steris Recalls QKC1692E Quick Connect Devices Due to Labeling Errors

Steris Corporation is recalling 64 QKC1692E Quick Connect devices because seven endoscope models were not validated for use with the device, requiring label corrections.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the issue is a labeling error due to unvalidated models rather than a direct safety hazard like contamination or malfunction. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls.

Plain-English summary

Steris Corporation is recalling 64 units of the QKC1692E Quick Connect device. This device is used to connect endoscopes to the sterilization tray for the C1220E liquid chemical sterilization processor. The recall is being conducted to correct labeling errors.

The recall was initiated because Steris was unable to obtain two specific devices needed for revalidation projects. These two devices represent the design of seven models in one quick connect. Due to the unavailability of these validation devices, Steris is removing these seven models from the labeling of the QKC1692E and will re-label all QKC1692Es in the field.

The affected units were distributed nationwide in the United States, including in the states of AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV. The affected lot numbers are 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, and 3094190. Users should check their devices against these lot numbers and contact Steris Corporation for re-labeling instructions.

The recalled product

Product
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Manufacturer
Steris Corporation
Affected units
64

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot numbers: 1879717
  • 1943786
  • 2054914
  • 2143717
  • 2177723
  • 2342319
  • 2730752
  • 2922565
  • 3094190

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically: