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U.S. Department of Health and Human Services

Class 2 Device Recall QKC1692E

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 Class 2 Recall
QKC1692E
see related information
Date Posted August 28, 2012
Recall Status1 Terminated on July 05, 2013
Recall Number Z-2284-2012
Recall Event ID 62776
Premarket Notification
510(K) Number
K090036 
Product Classification Sterilant, Medical Devices - Product Code MED
Product QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Code Information Lot numbers: 1879717, 1943786, 2054914, 2143717, 2177723, 2342319, 2730752, 2922565, 3094190
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Lindsey M. McGowan
440-392-7601
Manufacturer 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 2
DESIGN: Device Design
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 Kate_Beveridge@STERIS.com or via fax at (440) 350-7082. If you have any questions, contact Director, Regulatory Affairs at 440-392-7519.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = STERIS Corporation
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