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U.S. Department of Health and Human Services

Class 2 Device Recall MAJ1606 Instrument Channel Adaptor

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  Class 2 Device Recall MAJ1606 Instrument Channel Adaptor see related information
Date Initiated by Firm September 11, 2015
Date Posted October 08, 2015
Recall Status1 Terminated 3 on March 13, 2017
Recall Number Z-0113-2016
Recall Event ID 72242
510(K)Number K100899  
Product Classification Pump, air, non-manual, for endoscope - Product Code FEQ
Product MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
Code Information Models: Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces   Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536 
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
PO Box 610
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Customer Support
484-896-5688
Manufacturer Reason
for Recall		 small puncture marks in a sterile package for an accessory to an Olympus device
FDA Determined
Cause 2		 Process control
Action A letter of urgent device safety information, dated September 18, 2015, was sent to direct customers to inform them of the issue and instructions to cease use immediately. Customers were also asked to return the completed response form along with affected devices.
Quantity in Commerce 31060
Distribution US (nationwide) and Canada.
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 = FEQ and Original Applicant = KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
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