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U.S. Department of Health and Human Services

Class 2 Device Recall Steris QFC1728 and QFC1729 Quick Connects

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 Class 2 Recall
Steris QFC1728 and QFC1729 Quick Connects
see related information
Date Posted June 21, 2007
Recall Status1 Open
Recall Number Z-0967-2007
Recall Event ID 37493
Premarket Notification
510(K) Number
K875280 
Product Classification Sterilant, Medical Devices - Product Code MED
Product Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 is used to process 250/450 Group 5 and 530/590 series Endoscopes w/ Water Jet.
Code Information Lot numbers: 2914737, 2876316, 2871200, 2876274, 2914752, 2876704, 2876720, 2876746, 2876761, 3072030, and 3072014.
Recalling Firm/
Manufacturer
Steris Corp
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Holly Wright Lee
440-392-7019
Manufacturer Reason
for Recall
The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action On February 22, 2007, customers were contacted by phone and were notified by recall letter dated February 23, 2007. The recall notifications indicate that Steris Account managers will visit each consignee and replace affect product.
Quantity in Commerce 146
Distribution Worldwide-The product was distributed to USA domestic consignees located in MT, CA, NJ, IA, MA, WY, SC, MO, SC, TN, ID, MT, CO, PA, NV, and TX, and to foreign consignees located in Great Britian and Qatar.
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 C/O MEDICAL DEVICE CONSULTANTS, INC.
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