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U.S. Department of Health and Human Services

Class 2 Device Recall Steris Quick Connect (tethered)

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  Class 2 Device Recall Steris Quick Connect (tethered) see related information
Date Initiated by Firm March 07, 2003
Date Posted February 06, 2003
Recall Status1 Terminated 3 on February 05, 2004
Recall Number Z-0547-03
Recall Event ID 25374
510(K)Number k875280  
Product Classification Sterilizer, Chemical - Product Code MLR
Product C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.
Code Information Lot nos: 3508686 or smaller (C1406 and QLC1406); Lot nos: 3147303 or smaller (C1473 and QLC1473).
Recalling Firm/
Steris Corp
5960 Heisley Rd
Mentor OH 44060
Manufacturer Reason
for Recall
The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.
FDA Determined
Cause 2
Action On 3/14/2002 by mail and 2/21/2003 by fax. The units will be replaced.
Quantity in Commerce 1,140 units
Distribution Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = STERIS C/O MEDICAL DEVICE CONSULTANTS, INC.