Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Steris QFC1728 and QFC1729 Quick Connects 		see related information
Date Posted June 21, 2007
Recall Number Z-0967-2007
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
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
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.
 
-
-