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Terminated

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

FDA Recall Z-2284-2012 · Posted 2012-08-28

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMED
Date Initiated2012-08-10
Date Terminated2013-07-05
Product Quantity64 units

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..

Firm 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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090036SYSTEM 1.5 STERILE PROCESSING SYSTEMSTERIS Corporation · 2010-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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