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U.S. Department of Health and Human Services

Class 2 Device Recall Steris

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  Class 2 Device Recall Steris see related information
Date Initiated by Firm December 04, 2015
Create Date March 16, 2016
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-1180-2016
Recall Event ID 73009
510(K)Number K131078  
Product Classification Sterilant, medical devices - Product Code MED
Product Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
Code Information All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Ms. Kathryn E. Cadorette
440-392-7231
Manufacturer Reason
for Recall
The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 1/18/2016 the firm sent Voluntary Field Correction NOtices to their customers.
Quantity in Commerce 809 units
Distribution Worldwide distribution. US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.
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 = MED and Original Applicant = STERIS Corporation
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